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Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs

This study is ongoing, but not recruiting participants.
Sponsor:
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: August 18, 2014
Last verified: August 2014
  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:


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: December 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469585

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
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: August 18, 2014
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:
Metrorrhagia
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014