Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive

NCT ID: NCT00213096

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2004-02-29

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 estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.

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 estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Population Council

OTHER

Sponsor Role: lead

Principal Investigators

Regine Sitruk-Ware, MD

Role: PRINCIPAL_INVESTIGATOR

Population Council

Locations

Center for Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

HRN-A-00-99-00010

Identifier Type: -

Identifier Source: secondary_id

Population Council #323

Identifier Type: -

Identifier Source: org_study_id