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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01107093
Other study ID # 2914-007
Secondary ID
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


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
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