Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

NCT ID: NCT01469585

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-05-31

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.

Conditions

Breakthrough Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sub-antimicrobial doxycycline

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

Group Type: ACTIVE_COMPARATOR

Doxycycline

Intervention Type: DRUG

40 mg orally at the start of cycle 3 (study day 57) for 28 days.

Continuous Oral Contraceptive Pill

Women will take only the continuous oral contraceptive.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Doxycycline

40 mg orally at the start of cycle 3 (study day 57) for 28 days.

Intervention Type: DRUG

Other Intervention Names

Oracea

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Charles Drew University of Medicine and Science

OTHER

Sponsor Role: collaborator

Meharry Medical College

OTHER

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Bliss Kaneshiro

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bliss Kaneshiro, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii John A. Burns School of Medicine Department of Obstetrics and Gynecology

Locations

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

UH DOXY RTRN

Identifier Type: -

Identifier Source: org_study_id