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Clinical Trials/ACTRN12611000617965
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.

Registry
who.int
Start Date
June 16, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Dr Edith Weisberg

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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