NL-OMON42809
Completed
Not Applicable
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 selection - 151025-001
HRA Pharma0 sites30 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HRA Pharma
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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