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 ]

Baseline MMP expression will be determined on day 19-21 of cycle 1. During cycle 2, when women are taking the cyclic oral contraceptive, the EMB will be performed between cycle day 19-21 (study day 47-49), prior to endometrial degradation.


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 ]

Based on doxycycline's action as an MMP inhibitor, it is hypothesized that MMP expression and activity will be decreased in women taking sub-antimicrobial doxycycline compared to women on continuous oral contraceptives only. Because it is expensive to take sub-antimicrobial doxycycline for longer than 28 days, if it is to be clinically useful, it should have an appreciable effect on endometrial MMP levels after 28 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