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

Population Council

Status and phase

Completed

Phase 2

Conditions

Contraception

Treatments

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

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00213096

Population Council #323

HRN-A-00-99-00010

Details and patient eligibility

About

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.

Full description

Sex

Female

Ages

18 to 34 years old

Volunteers

Accepts Healthy Volunteers

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