Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

Breakthrough Bleeding Clinical Trial

Official title:

Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469585
• Other study ID #: UH DOXY RTRN
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2020
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breakthrough Bleeding
• Metrorrhagia

Intervention

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

Locations

Country	Name	City	State
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii

Sponsors (3)

Lead Sponsor	Collaborator
University of Hawaii	Charles Drew University of Medicine and Science, Meharry Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	49 days
Secondary	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)	84 days