Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs
This study is currently recruiting participants.
Verified March 2012 by University of Hawaii
Sponsor:
University of Hawaii
Collaborators:
Charles Drew University of Medicine and Science
Meharry Medical College
Information provided by (Responsible Party):
Bliss Kaneshiro, University of Hawaii
ClinicalTrials.gov Identifier:
NCT01469585
First received: November 8, 2011
Last updated: March 18, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breakthrough Bleeding |
Drug: Doxycycline |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Doxycycline
Doxycycline monohydrate
Doxycycline Hyclate
Doxycycline calcium
U.S. FDA Resources
Further study details as provided by University of Hawaii:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 14 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sub-antimicrobial doxycycline
Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.
|
Drug: Doxycycline
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women between the ages 18 and 45 who are ovulatory as demonstrated by a pre-treatment Progesterone (P) greater than or equal to 3.0 ng/mL prior to oral contraceptive use
Exclusion Criteria:
- Women with any absolute contraindications to EE and LNG;
- Women who are pregnant, breastfeeding or have POS;
- Use of oral contraceptives, patch, ring, intrauterine or implantable hormonal contraception within 4-weeks;
- Medroxyprogesterone acetate use within six months;
- Current use of drugs that interfere with sex steroid metabolism.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469585
Contacts
| Contact: Sara N Murakami, BS | 808-983-6224 | doxyinfo@crc.hawaii.edu |
Locations
| United States, Hawaii | |
| Kapiolani Medical Center for Women and Children | Recruiting |
| Honolulu, Hawaii, United States, 96826 | |
| Principal Investigator: Bliss Kaneshiro, MD, MPH | |
Sponsors and Collaborators
University of Hawaii
Charles Drew University of Medicine and Science
Meharry Medical College
Investigators
| Principal Investigator: | Bliss Kaneshiro, MD, MPH | University of Hawaii John A. Burns School of Medicine Department of Obstetrics and Gynecology |
More Information
No publications provided
| Responsible Party: | Bliss Kaneshiro, Assistant Professor, University of Hawaii |
| ClinicalTrials.gov Identifier: | NCT01469585 History of Changes |
| Other Study ID Numbers: | UH DOXY RTRN |
| Study First Received: | November 8, 2011 |
| Last Updated: | March 18, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Hawaii:
|
continuous oral contraceptives MMP expression |
Additional relevant MeSH terms:
|
Hemorrhage Metrorrhagia Adenoma Pathologic Processes Uterine Hemorrhage Uterine Diseases Genital Diseases, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined |
Doxycycline Doxycycline hyclate Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 23, 2013