Effects of SH T00658ID on Libido - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00764881

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 + Placebo	Phase III

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:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate Ethinyl estradiol-norgestrel combination

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The change in the not weighted sum of Female Sexual Function Index (FSFI) sexual desire and the sexual arousal component scores, defined as the total of questions 1 to 6 of the FSFI. [ Time Frame: Baseline to cycle 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The absolute values and changes in FSFI multidimensional self-report questionnaire (component scores desire, arousal, lubrication, orgasm, satisfaction and pain and total score). [ Time Frame: Baseline to cycle 2, cycle 4, cycle 6, and final visit ] [ Designated as safety issue: No ]
Female Sexual Distress Scale (FSDS-R) questionnaire results [ Time Frame: Screening, baseline, and cycles 2, 4, and 6 ] [ Designated as safety issue: No ]
Q-LES-Q (short version) questionnaire results [ Time Frame: Screening, baseline, and cycles 2, 4, and 6 ] [ Designated as safety issue: No ]
Psychological General Well-Being Index (PGWBI) questionnaire results [ Time Frame: Screening, baseline, and cycles 2, 4, and 6 ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) assessment [ Time Frame: Cycles 2, 4, 6 ] [ Designated as safety issue: No ]
Vaginal effects evaluated by: vaginal pH measurements, the Atrophy Symptom Questionnaire (ASQ), and the Vaginal Health Assessment (VHA) [ Time Frame: Screening, cylce 2, and final visit ] [ Designated as safety issue: No ]
Bleeding pattern and cycle control [ Time Frame: Throughout ] [ Designated as safety issue: No ]
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body Weight. [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

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: Arm 1	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.
Active Comparator: Arm 2	Drug: Microgynon + Placebo Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). 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

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

Locations

Australia, New South Wales

Adelaide, New South Wales, Australia, 5005

Ashfield, New South Wales, Australia, 2031

Sydney, New South Wales, Australia, 2031
Australia, Victoria

Prahran, Victoria, Australia, 3121
Australia, Western Australia

Nedlands, Western Australia, Australia, 6009

Subiaco, Western Australia, Australia, 6008
Austria

St. Pölten, NÖ, Austria, 3100

Graz, Steiermark, Austria, 8010

Graz, Steiermark, Austria, 8044

Wien, Austria, 1200

Wien, Austria, 1070

Wien, Austria, 1090

Zeltweg, Austria, 8740
Belgium

Bruxelles - Brussel, Belgium, 1070

Gent, Belgium, 9000

Leuven, Belgium, 3000
Germany

Freiburg, Baden-Württemberg, Germany, 79106

Aachen, Nordrhein-Westfalen, Germany, 52074

Leipzig, Sachsen, Germany, 04207

Hamburg, Germany, 20357
Italy

Cagliari, Italy, 09124

Catania, Italy, 95123

Pavia, Italy, 27100

Pisa, Italy, 56126
Spain

Gava, Barcelona, Spain, 08850

Alicante, Spain, 03013

Barcelona, Spain, 08028

Granada, Spain, 18014

Madrid, Spain, 28009
Thailand

Bangkok, Thailand, 10330

Bangkok, Thailand, 10400

Bangkok, Thailand, 10700

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00764881 History of Changes
Other Study ID Numbers:	91548, EudraCT: 2008-002263-13, 310785
Study First Received:	October 1, 2008
Last Updated:	August 2, 2010
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
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
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
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on February 12, 2012