Effects of SH T00658ID on Libido

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00764881
First received: October 1, 2008
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.


Condition Intervention Phase
Contraception
Libido
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Drug: Microgynon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).

  • Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).


Secondary Outcome Measures:
  • The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).

  • The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).

  • The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline. [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).

  • The Mean Absolute Values of FSFI Total Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).

  • The Mean Absolute Values of FSFI Total Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).

  • Mean Change From Baseline to Cycle 6 in FSFI Total Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).

  • The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).

  • The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).

  • Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).

  • The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).

  • The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).

  • Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.

  • Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).

  • Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

  • Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.

  • Vaginal Effects Evaluated by Vaginal pH at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick

  • Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).

  • Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).

  • Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).

  • Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).

  • Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).

  • Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA) [ Time Frame: Baseline up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).

  • Number of Bleeding / Spotting Days in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Number of Bleeding / Spotting Days in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to 180 during study treatment

  • Number of Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes

  • Number of Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment

  • Mean Length of Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes

  • Mean Length of Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Maximum Length of Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Maximum Length of Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Number of Spotting Only Days in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Number of Spotting Only Days in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Number of Spotting Only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Number of Spotting Only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Mean Length of Spotting-only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Mean Length of Spotting-only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Maximum Length of Spotting-only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Maximum Length of Spotting-only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1 [ Time Frame: From Day 1 to Day 90 ] [ Designated as safety issue: No ]
    Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.

  • Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2 [ Time Frame: From Day 91 to Day 180 ] [ Designated as safety issue: No ]
    Reference Period 2 is defined as Day 91 to Day 180 during study treatment.

  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  • Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  • Length of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  • Length of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  • Length of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end

  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

  • Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.

  • Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

  • Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

  • Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.

  • Onset of Withdrawal Bleeding Episodes at Cycle 1 [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1 ] [ Designated as safety issue: No ]
    Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

  • Onset of Withdrawal Bleeding Episodes at Cycle 3 [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3 ] [ Designated as safety issue: No ]
    Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

  • Onset of Withdrawal Bleeding Episodes at Cycle 6 [ Time Frame: From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6 ] [ Designated as safety issue: No ]
    Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.

  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Number of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Number of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Number of Intracyclic Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Maximum Length of Intracyclic Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Number of Intracyclic Bleeding Days at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Number of Intracyclic Bleeding Days at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Number of Intracyclic Bleeding Days at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.

  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1 [ Time Frame: At Cycle 1 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3 [ Time Frame: At Cycle 3 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

  • Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6 [ Time Frame: At Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.

  • Percentage of Participants With at Least 1 Intracyclic Bleeding Episode [ Time Frame: Up to Cycle 6 (28 days per Cycle) ] [ Designated as safety issue: No ]
    Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.


Enrollment: 217
Study Start Date: January 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EV/DNG (Natazia, Qlaira, BAY86-5027, SH T00658ID)
Daily oral administration of one capsule BAY86-5027 [estradiol valerate (EV) / dienogest (DNG)] for 28 days per cycle in the sequential 4-phasic regimen for 6 treatment cycles.
Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose
Active Comparator: EE/LNG (Microgynon) + Placebo
Daily oral administration of one capsule ethinylestradiol (EE) / levonorgestrel (LNG) for 21 days, followed by 1 capsule placebo for 7 days (28 days total per cycle) for 6 treatment cycles.
Drug: Microgynon
Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.
Drug: Placebo
Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon
  • Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion Criteria:

  • Contraindications for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764881

  Show 32 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00764881     History of Changes
Other Study ID Numbers: 91548, 2008-002263-13, 310785
Study First Received: October 1, 2008
Results First Received: July 28, 2011
Last Updated: April 1, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Thailand: Food and Drug Administration

Keywords provided by Bayer:
Oral contraceptive
Sexual dysfunction
Libido

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Levonorgestrel
Dienogest
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Contraceptives, Oral, Sequential
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on September 14, 2014