Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs|
- Determine the effect of combined oral contraceptives on endometrial MMP expression. [ Time Frame: 49 days ] [ Designated as safety issue: No ]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.
- Determine the effect of sub-antimicrobial doxycycline on MMP expression and activity in continuous oral contraceptive users. [ Time Frame: 84 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Sub-antimicrobial doxycycline
Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.
40 mg orally at the start of cycle 3 (study day 57) for 28 days.
Other Name: Oracea
No Intervention: Continuous Oral Contraceptive Pill
Women will take only the continuous oral contraceptive.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469585
|United States, Hawaii|
|Kapiolani Medical Center for Women and Children|
|Honolulu, Hawaii, United States, 96826|
|Principal Investigator:||Bliss Kaneshiro, MD, MPH||University of Hawaii John A. Burns School of Medicine Department of Obstetrics and Gynecology|