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

Population Council

Status and phase

Completed

Phase 2

Conditions

Contraception

Treatments

Drug: CDB-2914

Study type

Interventional

Funder types

Other

Identifiers

NCT00791297

Population Council #422

Details and patient eligibility

About

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:

follicular function and inhibition of ovulation
the endometrium
bleeding patterns; and also to assess safety including effects on the endometrium

Enrollment

55 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Women with high grade dysplasia are excluded
Women with low grade dysplasia or CIN I interpretation on Pap smear may participate based on Investigator discretion and provided there is appropriate follow up in accordance with local standards of care
Known benign or malignant liver tumors; known active liver disease
Cancer (past history of any carcinoma or sarcoma)
Medically diagnosed severe depression currently or in the past
Known or suspected alcoholism or drug abuse
Abnormal serum fasting clinical chemistry values
Women with known abnormal thyroid status
Women with known impaired hypothalamic-pituitary-adrenal reserve
Average diastolic BP > 85 mm or systolic BP >135 mm Hg after 5-10 minutes rest
Body mass index(BMI) > 29.0
Smoking in women who are 35 years and over or will be 35 years during the course of the trial; women < 35 years who smoke greater than 15 cigarettes per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism, e.g. lipid levels, glucose level, BP, BMI, family history of CVD at a young age
Women with severe cystoceles or rectoceles
Use within the past 2 months of any implanted hormonal contraceptives including Mirena [progestin containing intrauterine system (IUS)] or Norplant (subdermal implant delivering LNG) NOTE: Removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study
Current use of a non-hormone containing IUD. NOTE: Removal of an IUD must have been for personal reasons unrelated to the purpose of enrollment in this study
Use of injectable contraceptives during the previous 3 months (e.g. Cyclofem) or 6 months (e.g. DMPA)
Women who do not have at least two progesterone measurements during the control cycle of ≥10nmol/L will be excluded from further participation in the study (See Section 13.41)