Effects of SH T00658ID on Libido - Full Text View

Sponsored by:	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
Female Sexual Dysfunction	Drug: Encapsulated SH T00658ID Drug: Encapsulated Microgynon + placebo	Phase III

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	216
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Encapsulated 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.
Arm 2: Active Comparator	Drug: Encapsulated Microgynon + placebo Days 1 to 21: daily oral administration of one encapsulated Mircrogynon 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:

Subjects on oral contraceptives suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willing 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:

Women with any contraindication for oral contraceptive use, for example but not limited to: presence or a 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

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Belgium

GENT, Belgium, 9000
Germany, Baden-Württemberg / 274

Freiburg, Baden-Württemberg / 274, Germany, 79106
Germany, Hamburg / 287

Hamburg, Hamburg / 287, Germany, 20357
Spain

Madrid, Spain, 28009

Barcelona, Spain, 08025

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	91548, EudraCT: 2008-002263-13, 310785
Study First Received:	October 1, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00764881
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; United States: Institutional Review Board

Keywords provided by Bayer:

oral contraceptive
sexual dysfunction
libido
contraception

Study placed in the following topic categories:

Norgestrel
Levonorgestrel
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol

Ethinyl Estradiol-Norgestrel Combination
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol
Dienogest

Additional relevant MeSH terms:

Contraceptives, Postcoital, Synthetic
Estrogens
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Contraceptives, Postcoital
Hormones
Pharmacologic Actions
Contraceptives, Oral, Combined
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 13, 2009