Clinical Trial: Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs
Brief Summary: The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. This research is being done because currently, there is no effective treatment for this condition. Findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.
Detailed Summary:
Continuous oral contraceptive administration entails women taking hormonally active pills for 28 days without a seven day placebo week to avoid hormonal withdrawal bleeding. Unfortunately, with continuous administration, timed, regular bleeding can be replace by irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and the possibility of unplanned pregnancy.
MMPs, a group of zinc-dependant proteases, are hypothesized to play a role in endometrial degradation. The purpose of this study is to describe the expression of MMPs in endometrial biopsy (EMB) specimens collected 1) prior to initiating oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral contraceptives and 4) while taking continuous oral contraceptives along with sub-antimicrobial doxycycline.
Sponsor: University of Hawaii
Current Primary Outcome: Determine the effect of combined oral contraceptives on endometrial MMP expression. [ Time Frame: 49 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Determine the effect of sub-antimicrobial doxycycline on MMP expression and activity in continuous oral contraceptive users. [ Time Frame: 84 days ]
Original Secondary Outcome: Same as current
Information By: University of Hawaii
Dates:
Date Received: November 8, 2011
Date Started: November 2011
Date Completion: December 2014
Last Updated: August 18, 2014
Last Verified: August 2014