NCT00064766

Brief Summary

Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

July 11, 2003

Last Update Submit

June 23, 2005

Conditions

Endometrial BleedingPeriodontal Disease

Keywords

NorplantPeriodontal diseaseEndometrial bleedingProgestin-induced endometrial bleeding

Interventions

doxycyclineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regular menstrual periods for the last 2 cycles
  • Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry
  • Currently not using tetracycline-class antibiotics
  • Normal Pap smear

You may not qualify if:

  • Pregnancy or breastfeeding within 2 months of study entry
  • Chronic migraine headaches
  • Uncontrolled high blood pressure
  • Untreated sexually transmitted diseases
  • Alcoholism or drug abuse within 12 months of study entry
  • Insulin dependent diabetes
  • Liver, kidney, or gallbladder disease
  • Participation in another clinical trial within 30 days of study entry
  • History of cancer
  • History of blood clots, strokes, or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CONRAD Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • David F Archer, MD

    CONRAD Clinical Research Center, Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2003

First Posted

July 15, 2003

Study Start

February 1, 2003

Study Completion

February 1, 2005

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(1)