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

Inclusion Criteria1

  • Implanon users, with a complaint of episodes of prolonged (7 days or greater) or frequent (bleeding-free intervals of less than 15 days) bleeding. Women who are willing to participate in a research investigation of new approaches to the therapy of breakthrough bleeding.

Exclusion Criteria1

  • Women with contraindications to the use of oestrogen, anti-progesterone or tetracycline therapy; women with allergy to lactose; women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria.

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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