ACTRN12611000617965
Not yet recruiting
Phase 4
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 Weisberg0 sites200 target enrollmentJune 16, 2011
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- nacceptable bleeding pattern in women using the progestogen-only sub-dermal contraceptive implant
- Sponsor
- Dr Edith Weisberg
- Enrollment
- 200
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*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 Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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