NCT00791297

Brief Summary

The purpose of this study is to to determine pharmacodynamic effects of a vaginal ring delivering either 1,500 or 2,500 μg of CDB-2914 per day during 6 months of treatment on:

  1. 1.follicular function and inhibition of ovulation
  2. 2.the endometrium
  3. 3.bleeding patterns; and also to assess safety including effects on the endometrium

Trial Health

90
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach
3 countries

3 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

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

5.9 years

First QC Date

November 13, 2008

Last Update Submit

August 11, 2017

Conditions

Contraception

Keywords

CDB-2914Contraceptive Vaginal Ringsovulationendometrial changesbleeding patternsnormal cycling womenInhibition of ovulation, endometrial changes and bleeding patterns in normal cycling women

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable will be ovulation suppression measured by progesterone serum levels.

    All women will use the assigned CVR for 6 months

Secondary Outcomes (2)

  • Regular follow-up of follicle diameter will be made with USS to determine the timing of ovulation or, in the absence of ovulation, the fate of the dominant follicle.

    All women will use the assigned CVR for 6 months

  • Clinical safety will be evaluated and the effects on the endometrium will be measured.

    All women will use the assigned CVR for 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Contraceptive Vaginal Ring delivering a daily dose of 1500 μg of CDB-2914

Drug: CDB-2914

2

ACTIVE COMPARATOR

Contraceptive Vaginal Ring delivering a daily dose of 2500 μg of CDB-2914

Drug: CDB-2914

Interventions

CDB-2914DRUG

Contraceptive Vaginal Rings delivering a daily dose of 1500 or 2500 μg of CDB-2914

12

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women of reproductive age (21-40 years)
  • Not at risk for pregnancy based on one of the following
  • subject has undergone sterilization
  • subject is monogamous and her male partner has undergone sterilization
  • subject agrees to be abstinent for the entire duration of the study (Oregon site only)
  • subject does not have sex with men (Oregon site only)
  • Have regular menstrual cycles of 25-35 days duration
  • Have an intact uterus and both ovaries
  • Will be able to comply with the protocol
  • Capable of giving informed consent

You may not qualify if:

  • Women participating in another clinical trial
  • Women not living in the catchment area of the clinic
  • Known hypersensitivity to progestins or antiprogestins
  • Known hypersensitivity to silicone rubber
  • Any chronic disease
  • All contraindications to oral contraceptive use, including
  • Thrombophlebitis or thromboembolic disorders
  • Past history of deep vein thrombophlebitis or thromboembolic disorders
  • Past or current cerebrovascular or coronary artery disease
  • Migraine with focal aura
  • Known or suspected carcinoma of the breast
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Instituto Chileno de Medicina Reproductiva

Santiago, Chile

Location

Profamilia

Santo Domingo, Dominican Republic

Location

MeSH Terms

Interventions

ulipristal

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

October 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

US(1)CL(1)DO(1)