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

August 11, 2017 updated by: Population Council

A Randomized, Open-Label Study Comparing the Effect of a Contraceptive Vaginal Ring Delivering Daily Doses of 150 Micrograms Nestorone and 15 Micrograms Ethinyl Estradiol to an Oral Contraceptive Containing 150 Micrograms of Levonorgestrel and 30 Micrograms of Ethinyl Estradiol Per Tablet on Hepatic Factors Including Coagulation Factors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Center for Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Comparison of the differences between contraceptive vaginal ring and oral contraceptive treatment groups in change from baseline to end of treatment in serum angiotensinogen and sex-hormone binding globulin.

Secondary Outcome Measures

Outcome Measure
Comparison of the differences between contraceptive vaginal ring & oral contraceptive treatment groups in change from baseline to end of treatment in serum or plasma concentrations of 15 other hepatic proteins, coagulation factors & coagulation markers.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Council

Collaborators

United States Agency for International Development (USAID)

Investigators

  • Principal Investigator: Regine Sitruk-Ware, MD, Population Council

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2003

Study Completion (ACTUAL)

February 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 21, 2005

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Population Council #323
  • HRN-A-00-99-00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Contraception

Clinical Trials on Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe