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
Dr Edith Weisberg
200 participants
Jul 1, 2011
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
Inclusion Criteria3
- Implanon users, with a complaint of episodes of prolonged (10 days or greater) or frequent bleeding (more than 4 bleeding episodes in a 90 day reference period).
- Women who are willing to participate in a research investigation of new approaches for the management of troublesome bleeding.
- Women who are willing to maintain a 90 day bleeding diary prior to and post treatment initiation.
Exclusion Criteria14
- Women who have currently or previously had
- Heart attack or stroke
- Blood clot in a vein
- High blood pressure
- Severe liver or kidney disease
- Blood pressure > 135 mm systolic or >85 mm diastolic
- Migraine with aura
- Breast cancer or any genital cancer
- Severe chronic liver or kidney disease
- Women with known sensitivity to ethinyl oestradiol, progestogens
- Women taking phenytoin, carbamazepine or phenobarbitol
- Women who are pregnant
- Women who are lactating
- Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria
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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 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)
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ACTRN12611000617965