Contraceptive pill and hormonal vaginal ring in women with PCOS.
- Conditions
- Polycystic Ovary Syndrome (PCOS)Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2012-002220-32-FI
- Lead Sponsor
- OYS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 42
women aged between 18 to 40 years
-diagnosed PCOS (Rotterdam criteria)
-healthy, no medications
-no use of hormonal contraceptives or wash-out period of at least two months
-no contraindications to hormonal contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-regular smoking
-excessive alcohol use
-pregnancy or breastfeeding
-oversensitivity to active ingredients
-migraine with focal aura
-severe or multiple risk factors to thrombosis
-diagnosed or suspected cancer
-diagnosed or suspected estrogen-dependent tumor
-acute or chronic hepatocellular disease –related abnormal liver function
-hepatic adenomas or carcinomas
-undiagnosed abnormal vaginal bleeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to investigate the effects of vaginal and oral contraceptives on androgen secretion, insulin and glucose metabolism, lipid profile, and serum levels of SHBG and hs-CRP in women with PCOS. ;Secondary Objective: to investigate the effects after long term use and whether these contraceptives can be recommended to some group of women;Primary end point(s): Change in MATSUDA-index (1,65);Timepoint(s) of evaluation of this end point: After one year's use
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Other changes in hormonal, metabolic or inflammatory parameters;Timepoint(s) of evaluation of this end point: After one year's use