Mifepristone 50mg as a weekly Contraceptive
- Conditions
- Prevention of unwanted pregnancyTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2020-000866-41-Outside-EU/EEA
- Lead Sponsor
- Women on Web International Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Female
- Target Recruitment
- Not specified
1.no desire to become pregnant within the next 13 months
2.provision of signed and dated informed consent form for participation in the study
3.stated willingness to comply with all study procedures and availability for the duration of the study
4.female, aged 18-35
5.have a normal menstrual cycle of 25-35 days cycles which differ by no more than 3 days with less than 7 days of bleeding
6.at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss
7.be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month
8.be willing to use the study drug as the only method of contraception over the course of the study - if the potential participant is taking another contraceptive, they would have to stop and have one menstruation to be included in the trial
9.ability to take oral medication and be willing to adhere to the contraceptive regimen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 949
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.current pregnancy
2.within 3 months of delivery
3.abnormal cervical smear or within year before
4.known infertility or subfertility
5.history of ectopic pregnancy
6.any previous or current malignancy including breast cancer
7.abnormal liver enzymes
8.irregularities in endometrium
9.retained products of conception after miscarriage or abortion
10.signs of endometritis
11.known allergic reactions to mifepristone
12.lactation
13.using high doses of corticosteroids or any drugs that may interact with mifepristone - these include hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)
14.treatment with another investigational drug
15. unable to comply with the trial protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the contraceptive efficacy and safety of once a week mifepristone 50 mg.;Secondary Objective: To determine the side-effects and acceptability of once a week mifepristone 50 mg.;Timepoint(s) of evaluation of this end point: As indicated above;Primary end point(s): 1.Occurrence of pregnancy during treatment caused by method failure.<br>2.Proportion of women with endometrium thickness>15 mm, endometrium with irregular cystic appearance on US at baseline months 3, 6, months 9, months 13 and 2 months after end of treatment.<br>3.Proportion of women with ALAT, ASAT and bilirubin elevation three times above normal at baseline, months 3, months 6, months 9, months 13 and 2 months after end of treatment.<br>4.Proportion of women with adverse event / serious adverse event.<br>
- Secondary Outcome Measures
Name Time Method