Prospective, open-label, single arm study to assess the pharmacodynamics effects and safety of one dose of 30 mg ulipristal acetate (UPA) taken before dominant follicle selectio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

• Women aged 28-45 years at screening;• No current use of hormonal contraception (including IUS) and having had at least 2 complete menstrual cycles (3 bleeding episodes) since having stopped hormonal contraception before baseline cycle ;• Not at risk of pregnancy:
o not sexually active, or
o willing to protect all further acts of intercourse with condoms, or
o current use of Copper IUD
o having undergone surgical sterilization (tubal ligation), or
o partner sterilized or vasectomized ;• BMI < 30 kg/m2;• Willing not to use other hormonal methods of contraception until end of study;• Women able to give informed consent to participate in the study

Exclusion Criteria

• Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test ;• Currently breast-feeding;• Hypersensitivity to the active substance UPA or any of the excipients of the study treatment, namely lactose monohydrate, povidone K30, croscarmellose sodium and magnesium stearate;• Anomalies in safety labs done at screening visit recognized as clinically significant by the investigator;• Pap smear score >= 3 in the past 11 months;• Clinically significant abnormalities observed on TVU performed at screening visit ;• Cancer (past history of any carcinoma or sarcoma);• Chronic treatment with oral glucocorticoids ;• Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;• Known or suspected alcoholism or drug abuse;• Concomitant use of medication thought to interact with UPA (per SPCs);• Current participation in any other trial of an investigational medicine or participation in the month preceding the screening visit

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Follicular growth and the day of occurrence of ovulation during the treatment<br /><br>cycle</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Pharmacokinetic variables will be calculated for each subject and both<br /><br>analytes (UPA and 11-demethylated UPA)<br /><br>- Safety of treatment intake</p><br>