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 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月23日

试验速览

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•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

•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

发起方

HRA Pharma