Combined oral contraceptives plus spironolactone or cyproterone acetate for hirsutism: Randomized comparison of three regimens
Phase 1
Completed
- Conditions
- Metabolic and Endocrine - Other metabolic disordersThe treatment of moderate and severe hirsutism
- Registration Number
- ACTRN12609000604202
- Lead Sponsor
- Dr Sefa Kelekci
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Nulligravid women with moderate-to-severe hirsutism, non-pregnant women or women who do not wish to become pregnant, no smoking, no history of breast cancer and endometrium cancer, no active liver disease, no history of thromboembolic disease, no treatment for hirsutism before.
Exclusion Criteria
Subjects with thyroid disease, diabetes mellitus, adrenal disorders,
hyperprolactinemia, or any other disorder were excluded from the study. Women with hirsutism due to androgen excess such as late-onset congenital adrenal hyperplasia were not included in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The decrease in hirsutism score, which was always evaluated by the same physician by the modified Ferriman-Gallwey score, who was blinded to treatment groups.[At 3 rd and 6 th months after the start of treatment.]
- Secondary Outcome Measures
Name Time Method Changes in ovarian morphology (Policystic ovary or not by ultrasonography)[At 3 rd and 6 th months after the start of treatment. It was always evaluated by the same physician using ultrasonography, who was blinded to treatment groups.];Changes in serum androgen profiles regarding total testosterone, dehydroepiandrosterone sulphate and 17-hydroxyprogesterone[They were obtained at the early follicular phase of patents' spontaneous menstruation before, and on three and six months after treatment using radioimmunoassay commercial kits.]