Clinical trial NCT01107093: Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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

Primary outcomes:
measure: Inhibition of follicular rupture
timeFrame: within 6 days after treatment intake
Secondary outcomes:
measure: Appearance or absence of a corpus luteum
timeFrame: during the 6 days following treatment intake
measure: Growth pattern of leading follicle
measure: Presence or absence of a surge of serum luteinizing hormone (LH) levels
measure: Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length
measure: Incidence of intermenstrual bleeding and treatment-emergent adverse events
measure: Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline
measure: Incidence of ovarian cysts after CDB-2914 treatment
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: ICMER
city: Santo Domingo
country: Dominican Republic
facility: Clinica de PROFAMILIA
Study officials:
References:
citation: 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.