NCT00213096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

First QC Date

September 13, 2005

Last Update Submit

August 11, 2017

Conditions

Contraception

Keywords

Contraceptive agentsfemale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

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

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Drug Research

Leiden, Netherlands

Location

MeSH Terms

Interventions

ST 1435

Study Officials

  • Regine Sitruk-Ware, MD

    Population Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2003

Study Completion

February 1, 2004

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

NL(1)