RecruitingPhase 2ACTRN12605000206628

Control of menstrual bleeding disturbances in women using Implanon contraception

Randomised controlled trial of five treatments for women with breakthrough bleeding while using Implanon hormonal contraception to treat breakthrough bleeding (treatments options: placebo; mifepristone plus ethinyl oestradiol; doxycycline; doxycycline plus ethinyl oestradiol; doxycycline plus mifepristone)


Sponsor

FPA Health, 328 Liverpool Rd Ashfield NSW 2131

Enrollment

500 participants

Start Date

Apr 1, 2005

Study Type

Interventional

Conditions


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at the best way to manage unwanted bleeding patterns in women using the Implanon contraceptive implant (a small rod inserted under the skin that releases hormones). Some women using Implanon experience prolonged or frequent bleeding. The study compares different treatments to control this bleeding. You may be eligible if: - You are a woman between 18 and 45 years old - You are currently using Implanon as your contraceptive - You are experiencing prolonged bleeding (lasting 7 days or more) or frequent bleeding (with less than 15 days between bleeding episodes) - You are willing to keep a daily diary and follow the study guidelines You may NOT be eligible if: - You have a medical reason that prevents you from taking oestrogen, anti-progestogen, or tetracycline - You have an allergy to lactose - You are unwilling to keep a daily menstrual diary Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a randomised, controlled, double-blind trial of the effectiveness of four active treatments and placebo in the management of episodes of breakthrough bleeding in women using the progestogen-on

This is a randomised, controlled, double-blind trial of the effectiveness of four active treatments and placebo in the management of episodes of breakthrough bleeding in women using the progestogen-only, sub dermal implant contraceptive, Implanon. Implanon provides the near-zero-order release of the progestogen, etonogestrel, over a three year period. Treatment will be randomised to one of five arms. Each treatment will be given twice daily for 5 days in a complex arrangement which allows the following measurements: 1 Mifepristone 25mgs taken twice on day 1 followed by 4 days of ethinyl oestradiol, 20 micrograms each morning and placebo each evening. 2 Doxycycline 100mgs taken twice daily for 5 days. 3 Doxycycline 100mg plus ethinyl oestradiol 20 micrograms in the morning, and doxycycline 100 mg in the evening, for 5 days. 4 Doxycycline 100mg plus mifepristone 25mg twice on the first day and then doxycycline 100 mg taken twice daily for 4 days. Each of these blinded treatments will be taken once a month for 3 months.


Locations(1)

Australia

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ACTRN12605000206628