LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01254292
First received: November 22, 2010
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study.

Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.


Condition Intervention Phase
Contraception
Drug: Levonorgestrel IUD (LCS, BAY86-5028)
Drug: Yasmin (EE30/DRSP, BAY86-5131)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 µg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 µg Ethinyl Estradiol and 3 mg Drospirenone (Yasmin®) in Young Women (18-29 Years) Over 18 Months of Use

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF) [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.


Secondary Outcome Measures:
  • Overall Satisfaction Rating by the 5-point Likert Item at 6 Months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

  • Overall Satisfaction Rating by the 5-point Likert Item at 12 Months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

  • Overall Satisfaction Rating by the 5-point Likert Item at 18 Months [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

  • Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS) [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

  • Overall Satisfaction Rate at 6 Months (LOCF) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

  • Overall Satisfaction Rate at 12 Months (LOCF) [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.

  • User Satisfaction - Acceptability of the Administration of Study Treatment [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Choices Upon Completion of the Study [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Amount of Menstrual Bleeding [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Satisfaction With Menstrual Bleeding Pattern [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Frequency of Experiencing Unexpected Bleeding [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Satisfaction With Menstrual Bleeding Absence [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • User Satisfaction - Rating of Usual Menstrual Pain Intensity [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
  • EVAPIL-R Scores at Screening - Composite Score [ Time Frame: At screening ] [ Designated as safety issue: No ]
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

  • EVAPIL-R Scores at Screening - Bother Score [ Time Frame: At screening ] [ Designated as safety issue: No ]
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.

  • EVAPIL-R Scores at 6 Months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

  • EVAPIL-R Scores at 12 Months - Composite Score [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

  • EVAPIL-R Scores at 12 Months - Bother Score [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

  • EVAPIL-R Scores at 18 Months/EOS [ Time Frame: At 18 months/EOS ] [ Designated as safety issue: No ]
    The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.

  • Drop-out Rate [ Time Frame: At 6, 12 and 18 months ] [ Designated as safety issue: No ]

    The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated:

    • LCS12 expulsions
    • Bleeding pattern alterations
    • Bleeding pattern alterations with increased bleeding (amount)
    • Bleeding pattern alterations with decreased bleeding (amount)
    • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.

  • Pearl Index (PI) [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.

  • Compliance Rate for Yasmin Pill Intake [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of Participants With Partial or Total Expulsion [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.

  • Investigator's Evaluation of Successful IUS Insertion Procedure [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Participants' Evaluation of Pain During Successful IUS Insertion Procedure [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Investigator's Evaluation of IUS Removal Procedure [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Participants' Evaluation of Pain During IUS Removal Procedure [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Enrollment: 567
Study Start Date: January 2011
Study Completion Date: May 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCS12 (Skyla, BAY86-5028)
Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
Drug: Levonorgestrel IUD (LCS, BAY86-5028)
LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.
Active Comparator: EE30/DRSP (Yasmin, BAY86-5131)
Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Drug: Yasmin (EE30/DRSP, BAY86-5131)
Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has signed and dated the Informed Consent Form (ICF).
  • The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.
  • In the opinion of the investigator, the subject is

    • in good health;
    • without uterine conditions that would preempt insertion of LCS12;
    • without conditions/history that would contraindicate the use of oral contraceptives.
  • Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
  • As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
  • Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

  • Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
  • Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)
  • Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
  • Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
  • Any genital infection (until successfully treated)
  • Abnormal cervical smear result (see inclusion criteria)
  • Acute, current or history of recurrent pelvic inflammatory disease
  • Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.
  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: NCT01254292

  Show 47 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01254292     History of Changes
Other Study ID Numbers: 13362, 2010-020181-21
Study First Received: November 22, 2010
Results First Received: January 7, 2014
Last Updated: July 4, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation
United States: Food and Drug Administration

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
Drospirenone
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 19, 2014