prevent pregnancy
Conditions
Interventions
Trade Name: Ginestril
Product Name: mifepristone
Pharmaceutical Form: Tablet
Sponsors
women on web international foundation
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: To assess the contraceptive efficacy and safety of once a week mifepristone 50 mg. ;Secondary Objective: Secondary Objectives: To determine the side-effects and acceptability of once a week mifepristone 50 mg. ;Primary end point(s): Primary Endpoints: 1. Occurrence of pregnancy during treatment caused by method failure. 2. Proportion of women with endometrium thickness>15 mm, endometrium with irregular cystic appearance on US at baseline months 3, 6, 9, 13 and time to normalisation after end of treatment. 3. Proportion of women with ALAT, ASAT and bilirubin elevation three times above normal at baseline, months 3, 6, 9, 13 and time to normalisation after end of treatment. 4. Proportion of women with adverse event / serious adverse event ;Timepoint(s) of evaluation of this end point: when 33% and 66% of participants completed the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1. Occurrence of pregnancy during treatment caused by user failure. 2. Proportion of women with blood hormone levels abnormalities. 3. Proportion of women with anovulatory cycles. 4. Proportion of women with endometrial changes (PAEC) confirmed by biopsy at baseline, months 3, 6, 9, 13 and time to normalisation after end of treatment. 5. Proportion of women with normal haemoglobin value at baseline, months 3, 6, 9, 13. 6. Mean value of quality of life questionnaire (EQ-5D-5L) at baseline, months 3, 6, 9, 13. 7. Proportion of women who uses antidepressants at baseline and during the study. 8. Proportion of women with dysmenorrhea (diary continued measurement) during the study. 9. Proportion of women with acne occurrence (diary continued reporting) during the study. 10. Proportion of women with side-effects (headache, nausea, breast pain, dry eyes) (diary continued reporting) during the study. 11. Mean weight changes at 3 months, 6 months, 9 months, 13 months compared to baseline. 12. Proportion of women with vaginal bleeding (diary continued measurement) 13. Libido: mean value of Female Sexual Function Index (FSFI) at baseline, months 3, 6, 9, 13.;Timepoint(s) of evaluation of this end point: when 33% and 66% of participants completed the study | — |
Countries
Moldova, Republic of
Contacts
Public Contactrebecca gomperts
women on waves
Outcome results
None listed