Mifepristone 50 mg as weekly contraceptive

Phase 1

• Conditions: prevent pregnancy; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2020-002355-38-Outside-EU/EEA
• Lead Sponsor: women on web international foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-29
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

female, 18-35 years; no desire to become pregnant within the next 13 months; 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; at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss; be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month; be willing to use the study drug as the only method of contraception
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 0

Exclusion Criteria

known infertility or subfertility; current pregnancy, within 3 months of delivery; lactation; abnormal cervical smear or within year before; history of ectopic pregnancy; any previous or current malignancy including breast cancer; abnormal liver enzymes; irregularities in endometrium; retained products of conception after miscarriage or abortion; signs of endometritis; known allergic reactions to mifepristone; 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); treatment with another investigational drug (until next normal period after stopping other trial); unable to comply with the trial protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified