Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914

Completed · Phase 2

Conditions studied: Contraception

In brief

The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on: 1. follicular function and inhibition of ovulation 2. the endometrium 3. bleeding patterns; and also to assess safety including effects on the endometrium

Key facts

Study ID

NCT00791297

Run by

Population Council

People needed

55

Starts

2008-10-01

Expected to finish

2014-09-01

Last updated by the study team

2017-08-15

Who can join

Age: 21 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy women of reproductive age (21-40 years)
• Not at risk for pregnancy based on one of the following
• subject has undergone sterilization
• subject is monogamous and her male partner has undergone sterilization
• subject agrees to be abstinent for the entire duration of the study (Oregon site only)
• subject does not have sex with men (Oregon site only)
• Have regular menstrual cycles of 25-35 days duration
• Have an intact uterus and both ovaries
• Will be able to comply with the protocol
• Capable of giving informed consent

You may not qualify if…

• Women participating in another clinical trial
• Women not living in the catchment area of the clinic
• Known hypersensitivity to progestins or antiprogestins
• Known hypersensitivity to silicone rubber
• Any chronic disease
• All contraindications to oral contraceptive use, including
• Thrombophlebitis or thromboembolic disorders
• Past history of deep vein thrombophlebitis or thromboembolic disorders
• Past or current cerebrovascular or coronary artery disease
• Migraine with focal aura
• Known or suspected carcinoma of the breast
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Hepatic adenomas or carcinomas
• Known or suspected pregnancy
• Desire to get pregnant during the study (through the use of reproductive technology for sterilized women or vasectomy reversal for sterilized partners)
• Breastfeeding
• Undiagnosed vaginal discharge or vaginal lesions or abnormalities
• Elevated Prolactin levels (above laboratory normal values)
• Women with a current abnormal Pap
• In accordance with the Bethesda system of classification smear suggestive of high-grade pre-cancerous lesion(s), including HGSIL, are excluded
• Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity > CIN I is present and/or endocervical curettage is negative
• Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded it treatment is indicated
• In accordance with other Pap class systems

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States
• Instituto Chileno de Medicina Reproductiva — Santiago, Chile
• Profamilia — Santo Domingo, Dominican Republic

Full record on ClinicalTrials.gov

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