NCT01469585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

November 8, 2011

Results QC Date

May 22, 2018

Last Update Submit

November 23, 2020

Conditions

Breakthrough Bleeding

Keywords

continuous oral contraceptivesMatrix Metalloproteinase expression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Matrix Metalloproteinase Expression and Activity by Gel Densitometry

    84 days

Study Arms (2)

Sub-antimicrobial doxycycline

ACTIVE COMPARATOR

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

Drug: Doxycycline

Continuous Oral Contraceptive Pill

NO INTERVENTION

Women will take only the continuous oral contraceptive.

Interventions

DoxycyclineDRUG

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

Also known as: Oracea
Sub-antimicrobial doxycycline

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Investigator
Organization
University of Hawaii
blissk@hawaii.edu
808-203-6500

Study Officials

  • Bliss Kaneshiro, MD, MPH

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 10, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

December 17, 2020

Results First Posted

December 17, 2020

Record last verified: 2020-11

Locations

US(1)