Full Text View
Tabular View
No Study Results Posted
Related Studies
Effects of SH T00658ID on Libido
This study is currently recruiting participants.
Verified by Bayer, October 2009
First Received: October 1, 2008   Last Updated: October 1, 2009   History of Changes
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: 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

Resource links provided by NLM:

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate 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 ]

Estimated Enrollment: 216
Study Start Date: January 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental 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.
Arm 2: Active Comparator 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

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 32 Study Locations
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
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

No publications provided

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, 2009
ClinicalTrials.gov Identifier: NCT00764881     History of Changes
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:
Contraceptives, Postcoital, Synthetic
Estrogens
Contraceptive Agents
Estradiol valerate
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
 Reproductive Control Agents
Contraceptives, Postcoital
Hormones
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral, Sequential
Therapeutic Uses
Contraceptives, Oral, Synthetic
Ethinyl Estradiol-Norgestrel Combination

ClinicalTrials.gov processed this record on November 27, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services