Trial Outcomes & Findings for Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases (NCT NCT01469585)

Last Updated: 2020-12-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

49 days

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Sub-antimicrobial Doxycycline Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill. Doxycycline: 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.
Overall Study STARTED	11	9
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: Subantimicrobial Doxycycline n=11 Participants Active comparator: Subantimicrobial doxycycline	No Intervention: Continuous Oral Contraceptive Pill n=9 Participants No intervention: Continuous oral contraceptive pill	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 49 days

Outcome measures

Outcome measures
Measure	Sub-antimicrobial Doxycycline Group n=11 Participants Sub-antimicrobial doxycycline group (controlled release subantimicrobial doxycycyline 40 mg once daily)	Control n=9 Participants Control (no medication)
Endometrial Matrix Metalloproteinase Expression by Gel Densitometry	1.33 relative expression Standard Deviation 0.41	2.49 relative expression Standard Deviation 0.72

SECONDARY outcome

Timeframe: 84 days

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)

Outcome measures

Outcome measures
Measure	Sub-antimicrobial Doxycycline Group n=4 Participants Sub-antimicrobial doxycycline group (controlled release subantimicrobial doxycycyline 40 mg once daily)	Control n=6 Participants Control (no medication)
Matrix Metalloproteinase Expression and Activity by Gel Densitometry	1.52 relative expression Standard Deviation 0.63	1.98 relative expression Standard Deviation 0.87

Adverse Events

Sub-antimicrobial Doxycycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous Oral Contraceptive Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Investigator

University of Hawaii

Phone: 808-203-6500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place