NCT01107093

Brief Summary

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:

  • echographic follicle rupture
  • inhibition of follicle rupture
  • luteal phase progesterone levels
  • anovulatory progesterone levels

Trial Health

90
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 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

May 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

7 months

First QC Date

April 12, 2010

Last Update Submit

August 24, 2010

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • Inhibition of follicular rupture

    Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment

    within 6 days after treatment intake

Secondary Outcomes (7)

  • Appearance or absence of a corpus luteum

    during the 6 days following treatment intake

  • Growth pattern of leading follicle

  • Presence or absence of a surge of serum luteinizing hormone (LH) levels

  • Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length

  • Incidence of intermenstrual bleeding and treatment-emergent adverse events

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

CDB-2914

ACTIVE COMPARATOR
Drug: CDB-2914 (ulipristal acetate)

Interventions

CDB-2914 (ulipristal acetate)DRUG

single oral dose of 30 mg

CDB-2914
PlaceboDRUG

single oral dose

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women of good general health aged 18 - 35 years
  • Not at risk of pregnancy
  • Regular menstrual cycles of 24-35 days duration
  • Not pregnant
  • Intact uterus and ovaries
  • Haemoglobin ≥ 11 g/dl
  • Normal laboratory tests and normal TSH
  • Willing to abstain from any use of hormonal contraception until study completion
  • No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception
  • Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion
  • Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles

You may not qualify if:

  • Current participation in any other trial of an investigational medicine
  • Known hypersensitivity to the ingredients of the test active substances or excipients
  • Suspected hyperplasia or carcinoma of the endometrium
  • Current pregnancy as confirmed by positive serum beta-hCG at screening
  • Desire to get pregnant before the planned end of the study participation
  • Currently breastfeeding
  • Abnormal Pap smear
  • Cancer (past history of any carcinoma or sarcoma)
  • Known or suspected alcoholism or drug abuse
  • Abnormal thyroid status
  • Body mass index \> 32
  • Current use of hormonal contraception
  • Use of hormonal emergency contraception since last menstrual period
  • Severe asthma insufficiently controlled by oral glucocorticoids
  • Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ICMER

Santiago, Chile

Location

Clinica de PROFAMILIA

Santo Domingo, Dominican Republic

Location

Related Publications (1)

  • Brache V, Cochon L, Jesam C, Maldonado R, Salvatierra AM, Levy DP, Gainer E, Croxatto HB. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010 Sep;25(9):2256-63. doi: 10.1093/humrep/deq157. Epub 2010 Jul 15.

    PMID: 20634186RESULT

MeSH Terms

Interventions

ulipristalulipristal acetate

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 20, 2010

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 25, 2010

Record last verified: 2010-08

Locations

CL(1)DO(1)