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Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

Primary Purpose

Breakthrough Bleeding

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breakthrough Bleeding focused on measuring continuous oral contraceptives, Matrix Metalloproteinase expression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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 ethinyl estradiol and levonorgestrel;
  • Women who are pregnant or breastfeeding
  • 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.

Sites / Locations

  • Kapiolani Medical Center for Women and Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sub-antimicrobial doxycycline

Continuous Oral Contraceptive Pill

Arm Description

Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.

Women will take only the continuous oral contraceptive.

Outcomes

Primary Outcome Measures

Endometrial Matrix Metalloproteinase Expression by Gel Densitometry
Baseline Matrix Metalloproteinase expression (activity level) will be determined on day 19-21 of cycle 1. During cycle 2, when women are taking the cyclic oral contraceptive, the endometrial biopsy will be performed between cycle day 19-21 (study day 47-49), prior to endometrial degradation and activity level will be noted. Of note, the outcome is MMP activity level, not a change in level.

Secondary Outcome Measures

Matrix Metalloproteinase Expression and Activity by Gel Densitometry
Based on doxycycline's action as an Matrix Metalloproteinase inhibitor, it is hypothesized that Matrix Metalloproteinase expression and activity level will be decreased in women taking sub-antimicrobial doxycycline compared to women on continuous oral contraceptives only. The outcome is activity level (not a change in activity level)

Full Information

First Posted
November 8, 2011
Last Updated
November 23, 2020
Sponsor
University of Hawaii
Collaborators
Charles Drew University of Medicine and Science, Meharry Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01469585
Brief Title
Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases
Official Title
Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hawaii
Collaborators
Charles Drew University of Medicine and Science, Meharry Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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. Matrix Metalloproteinases, 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 Matrix Metalloproteinases in endometrial biopsy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Bleeding
Keywords
continuous oral contraceptives, Matrix Metalloproteinase expression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sub-antimicrobial doxycycline
Arm Type
Active Comparator
Arm Description
Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.
Arm Title
Continuous Oral Contraceptive Pill
Arm Type
No Intervention
Arm Description
Women will take only the continuous oral contraceptive.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Oracea
Intervention Description
40 mg orally at the start of cycle 3 (study day 57) for 28 days.
Primary Outcome Measure Information:
Title
Endometrial Matrix Metalloproteinase Expression by Gel Densitometry
Description
Baseline Matrix Metalloproteinase expression (activity level) will be determined on day 19-21 of cycle 1. During cycle 2, when women are taking the cyclic oral contraceptive, the endometrial biopsy will be performed between cycle day 19-21 (study day 47-49), prior to endometrial degradation and activity level will be noted. Of note, the outcome is MMP activity level, not a change in level.
Time Frame
49 days
Secondary Outcome Measure Information:
Title
Matrix Metalloproteinase Expression and Activity by Gel Densitometry
Description
Based on doxycycline's action as an Matrix Metalloproteinase inhibitor, it is hypothesized that Matrix Metalloproteinase expression and activity level will be decreased in women taking sub-antimicrobial doxycycline compared to women on continuous oral contraceptives only. The outcome is activity level (not a change in activity level)
Time Frame
84 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 ethinyl estradiol and levonorgestrel; Women who are pregnant or breastfeeding 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bliss Kaneshiro, MD, MPH
Organizational Affiliation
University of Hawaii John A. Burns School of Medicine Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

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