NCT00271583

Brief Summary

Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed) The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,672

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1999

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2006

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

December 29, 2005

Last Update Submit

December 13, 2007

Conditions

Emergency Contraception

Keywords

emergency contraceptionantiprogestin

Outcome Measures

Primary Outcomes (1)

  • Pregnancy (efficacy)

    until follow-up about one week after next menses

Secondary Outcomes (2)

  • Tolerability (side effects)

    until follow-up about one week after next menses

  • Menstrual cycle effects

    until follow-up about one week after next menses

Interventions

CDB-2914DRUG
levonorgestrelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Menstruating women at least 18 years old;
  • Give voluntary, written informed consent, and agree to observe all study requirements;
  • Request emergency contraception within 72 hours (3 days) after unprotected coitus, as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
  • Reports that all acts of unprotected coitus during the current cycle are within 72 hours prior to enrollment;
  • Willing to abstain from further acts of unprotected intercourse during that cycle;
  • History of regular menstrual cycles (mean length of 24-42 days with intra-individual variation of ±5 days);
  • At least one normal menstrual cycle (2 menses) post delivery or abortion;
  • If subject recently discontinued hormonal contraception, one normal menstrual cycle (2 menses) must have been completed before entry in the study
  • For women with a recent history of Depo Provera use, the most recent injection must be at least 3 months before study entry and the subject must have had at least one normal menstrual cycle (2 menses);
  • Available for follow-up for at least the next four weeks.

You may not qualify if:

  • Currently pregnant (positive high-sensitivity urine pregnancy test);
  • pregnant or breast-feeding within the past two months;
  • use of hormonal methods of contraception during the current or previous two cycles;
  • current user of IUD;
  • tubal ligation;
  • partners with history of vasectomy;
  • unsure about the date of the last menstrual period (+3 days);
  • nausea and vomiting within the previous two weeks;
  • impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.
  • Subjects cannot be currently enrolled in any other investigational trial or re-enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

California Family Health Council

Los Angeles, California, United States

Location

University of Colorado

Denver, Colorado, United States

Location

New York University

New York, New York, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15215, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, United States

Location

Related Publications (1)

  • Creinin MD, Schlaff W, Archer DF, Wan L, Frezieres R, Thomas M, Rosenberg M, Higgins J. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006 Nov;108(5):1089-97. doi: 10.1097/01.AOG.0000239440.02284.45.

    PMID: 17077229RESULT

MeSH Terms

Interventions

ulipristalLevonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Diana Blithe, PhD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2005

First Posted

January 2, 2006

Study Start

September 1, 1999

Study Completion

September 1, 2001

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

US(6)