Not Yet RecruitingPhase 4ACTRN12611000617965

New treatments for troublesome bleeding in Implanon users

Comparison of two combined oral contraceptive regimens and an intravaginal hormonal ring against placebo for management of bleeding problems in women using Implanon, the sub-dermal contraceptive implant


Sponsor

Dr Edith Weisberg

Enrollment

200 participants

Start Date

Jul 1, 2011

Study Type

Interventional

Conditions

Summary

Recruited subjects will maintain a daily menstrual diary chart for a minimum of 90 days, and will be enrolled into the treatment phase provided that they have met one of the World Health Organization criteria for prolonged or frequent bleeding (in the 90 day reference period one episode of bleeding and/or spotting lasting > 10 days, or more than 4 bleeding/spotting episodes) Following the initial 90 day record, women will begin designated treatment on day 1 of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of treatment and will continue through 90 days. Analysis of the pre-treatment menstrual pattern will include the 90 days immediately preceding the bleeding episode in which treatment starts. Menstrual pattern analysis will be carried out according to World Health Organization definitions and clinically important bleeding pattern criteria.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests new treatments for troublesome bleeding caused by the Implanon contraceptive implant in women aged 18 to 45. Participants must be experiencing prolonged or frequent bleeding episodes and be willing to keep a 90-day bleeding diary. Women who are pregnant, breastfeeding, or have a history of blood clots or breast cancer are excluded.

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

To set up and perform a pilot double-blind randomised clinical Randomised trial of two regimens and an open-label arm to examine the effects of the following treatments on prolonged or frequent uterin

To set up and perform a pilot double-blind randomised clinical Randomised trial of two regimens and an open-label arm to examine the effects of the following treatments on prolonged or frequent uterine bleeding in women using Implanon, the etonogestrel-releasing sub dermal contraceptive implant: *7 days daily intake of oral capsule containing containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules *21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms *21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days *21 days daily oral placebo capsules Treatment will be for one cycle of 21 days


Locations(1)

Australia

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ACTRN12611000617965