Status:
COMPLETED
Effects of SH T00658ID on Libido
Lead Sponsor:
Bayer
Conditions:
Contraception
Libido
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
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 yea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00764881
Start Date
January 1 2009
End Date
July 1 2010
Last Update
December 30 2014
Active Locations (32)
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1
Sydney Centre for Reproductive Health Reseach
Ashfield, New South Wales, Australia, 2031
2
Royal Hospital for Women
Sydney, New South Wales, Australia, 2031
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
The Alfred Hospital
Prahran, Victoria, Australia, 3121