Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

Contraception Clinical Trial

Official title:

A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107093
• Other study ID #: 2914-007
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: August 24, 2010
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2010
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de ChileDominican Republic: Consejo Nacional de Bioetica en Salud
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• CDB-2914 (ulipristal acetate)
single oral dose of 30 mg
• Placebo
single oral dose

Locations

Country	Name	City	State
Chile	ICMER	Santiago
Dominican Republic	Clinica de PROFAMILIA	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Countries where clinical trial is conducted

Chile,  Dominican Republic, 

References & 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/d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Appearance or absence of a corpus luteum		during the 6 days following treatment intake	No
Secondary	Growth pattern of leading follicle	number of cycles exhibiting atresia (diameter decrease =25%), or continued growth (diameter increase =25%), or interrupted growth (size remains within ±25% of the follicle size at the time of treatment)		No
Secondary	Presence or absence of a surge of serum luteinizing hormone (LH) levels	The onset of an LH surge is defined as the occurrence of the first single serum LH value whose level is at least 50% higher than the mean of the last two previous measurements, or higher than the last previous measurement if only one previous LH level is available.		No
Secondary	Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length			Yes
Secondary	Incidence of intermenstrual bleeding and treatment-emergent adverse events			Yes
Secondary	Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline			Yes
Secondary	Incidence of ovarian cysts after CDB-2914 treatment			Yes