Mifepristone ovarian function study
Phase 3
Recruiting
- Conditions
- Other - Cervical (Cervix)The effect of administering a progestogen receptor modulator with or without oestrogen on the ovarian function and quality of cervical mucus in women using the progestogen-only sub-dermal contraceptive, Implanon.
- Registration Number
- ACTRN12605000698673
- Lead Sponsor
- FPA Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Implanon users, who have been using Implanon for three months.Women who are willing to participate in a research investigation of new approaches to the therapy of breakthrough bleeding.Women who are prepared to have regular venepuncture, vaginal ultrasound and cervical mucus collection over a period of four weeks.
Exclusion Criteria
Pregnancy. Women who have currently or previously had Heart attack or strokeBlood clot in a veinHigh blood pressureSevere liver or kidney diseaseBlood pressure >160mm systolic or >95mm diastolicFocal migraineBreast cancer or any genital cancerWomen with known sensitivity to ethinyl oestradiol, or lactoseWomen taking phenytoin, carbamazepine or phenobarbitol or Women who are lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progestogen level >9nmol/L in any of the serum samples taken[Serum samples taken 2 days prior to treatment, 2 and 6 days after treatment has been started and then twice weekly for 3 weeks]
- Secondary Outcome Measures
Name Time Method Mean maximum size of ovarian follicles[Cervical mucus score assessed for the individual woman at each visit and the mean score at the end of the 4 week study.]