| October 1, 2008 |
| October 1, 2009 |
| January 2009 |
| September 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00764881 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Effects of SH T00658ID on Libido |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
|
|
- Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
- Drug: Microgynon + Placebo
|
| |
| |
| |
| Recruiting |
| 216 |
| September 2010 |
| September 2010 (final data collection date for primary outcome measure) |
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
|
| Female |
| 18 Years to 50 Years |
| No |
|
|
| Australia, Austria, Belgium, Germany, Italy, Spain, Thailand |
| |
| NCT00764881 |
| Therapeutic Area Head, Bayer HealthCare AG |
| 91548, EudraCT: 2008-002263-13, 310785 |
| Bayer |
|
| Study Director: |
Bayer Study Director |
Bayer |
|
|
| Bayer |
| October 2009 |
