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

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
Population Council
ClinicalTrials.gov Identifier:
NCT00213096
First received: September 13, 2005
Last updated: May 30, 2006
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Population Council:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 50
Study Start Date: March 2003
Estimated Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213096

Locations
Netherlands
Center for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Population Council
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Regine Sitruk-Ware, MD Population Council
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213096     History of Changes
Other Study ID Numbers: Population Council #323, HRN-A-00-99-00010
Study First Received: September 13, 2005
Last Updated: May 30, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Population Council:
Contraceptive agents
female

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
ST 1435
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on July 26, 2014