Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs
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|ClinicalTrials.gov Identifier: NCT01469585|
Recruitment Status : Unknown
Verified August 2014 by Bliss Kaneshiro, University of Hawaii.
Recruitment status was: Active, not recruiting
First Posted : November 10, 2011
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breakthrough Bleeding||Drug: Doxycycline||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2014|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|