Status:
COMPLETED
Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive
Lead Sponsor:
Population Council
Collaborating Sponsors:
United States Agency for International Development (USAID)
Conditions:
Contraception
Eligibility:
FEMALE
18-34 years
Phase:
PHASE2
Brief Summary
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to ...
Detailed Description
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to ...
Eligibility Criteria
Inclusion
- Healthy women, aged 18-34 years, who did not wish to become pregnant for 3 months (or 5 months if first discontinuing oral contraceptives
- Intact uterus and at least 1 ovary
- Have regular menstrual cycles (28 ± 7 days) or 2 regular cycles after parturition or abortion
- Willing to use condoms while having sexual intercourse during the 3 month study (or 5 months if discontinuing oral contraceptives), or
- Willing to continue use of a specified non-hormonal method of birth control including permanent sterilization, non-hormone-containing IUD, male condoms, or abstinence during the study or to use condoms if discontinuing one of these methods
- Willing and able to comply with the protocol
- Willing and able to sign informed consent prior to entry into the study and prior to discontinuing another method of contraception
- Easy venous access
Exclusion
- Pregnancy
- Known hypersensitivity to estrogens or progestins
- Known hypersensitivity to silicone rubber
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- Smoking status: \>15 cigarettes per day
- Breastfeeding
- Current or past thrombophlebitis or thromboembolic disorders
- Family history of venous thrombosis or embolism (1st degree relatives \<55 years of age)
- Known history of Factor V Leiden or positive screening test for APC-resistance
- Current or past cerebrovascular or coronary artery disease
- Carcinoma (hormone-dependent tumor; past history of any carcinoma not in remission for \>5 years)
- Medically diagnosed severe depression
- Headaches with focal neurological symptoms
- Undiagnosed abnormal genital bleeding
- History of cholestatic jaundice of pregnancy or jaundice with prior steroid use
- Benign or malignant liver tumors; active liver disease
- Diastolic/systolic BP ≥90/140 mmHg after 5 min. rest
- Known or suspected alcoholism (\>2 drinks/day)or drug abuse
- Positive for hepatitis B \& C and/or HIV 1 or 2, abnormal screening CBC, serum chemistry values (including fasting, total cholesterol and triglycerides), abnormal Pap smear, abnormal findings on dipstick urinalysis, or an abnormal electrocardiogram (ECG)
- Participation in a clinical trial within last 3 months or more than 1 trial in the last year
- BMI (kg/m2) \>28
- Use of injectable contraceptives in last 6 months (e.g. cyclofem or DMPA)
- Unwilling to stop oral contraceptives for 2 months prior to study initiation
- Use of implanted hormonal contraceptives, including Mirena or Implanon, in last 2 years
- Not living in the catchment area of the clinic\*Severe cystoceles or rectoceles
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00213096
Start Date
March 1 2003
End Date
February 1 2004
Last Update
August 14 2017
Active Locations (1)
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1
Center for Human Drug Research
Leiden, Netherlands