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A Prospective Randomized Clinical Trial of Doxycycline 20mg Twice a Day Versus Placebo on the Bleeding and Spotting in Women After Insertion of a Levonorgestrel Implant (Norplant) Protocol #2002-1


Phase 4
18 Years
40 Years
Open (Enrolling)
Female
Endometrial Bleeding, Periodontal Disease

Thank you

Trial Information

A Prospective Randomized Clinical Trial of Doxycycline 20mg Twice a Day Versus Placebo on the Bleeding and Spotting in Women After Insertion of a Levonorgestrel Implant (Norplant) Protocol #2002-1


A high percentage of women using progestin-only contraception experience breakthrough
bleeding (BTB) and spotting that causes impaired lifestyle and results in decreased
compliance with this contraceptive method. There is a need for an effective, low-cost,
easily adapted treatment to reduce the bleeding and spotting in progestin-only
contraceptives. The molecular environment of the endometrium of women with BTB and spotting
contains abnormally high levels of pro-inflammatory cytokines (TNF-alpha and IL-1 beta) and
abnormally high levels of proteases (matrix metalloproteinases [MMPs] and neutrophil
elastase), which prevent normal tissue repair. Doxycycline (DOX) is an inexpensive, FDA
approved antibiotic that inhibits MMPs and reduces nitric oxide synthesis. This study will
evaluate DOX treatment of progestin-only contraceptive induced BTB and spotting,
characterize the endometrial molecular biologic changes that occur in DOX treated patients,
and determine the effect of Norplant on sexual functioning and testosterone levels.

All participants in this study will receive Norplant. Participants will then be randomized
to receive either DOX (20 mg twice a day) or placebo for 6 months. Participants will have 9
study visits during the 24 weeks of the study. Study visits will include a medical history,
physical exam, and blood and urine tests. Participants will also have three periodontal
evaluations and three endometrial biopsies. At the end of the study, participants may
choose to have the Norplant implant removed if they wish to discontinue Norplant use;
otherwise the implant may remain in for up to 5 years.

Inclusion Criteria


Inclusion Criteria

- 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

Exclusion criteria

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

David F Archer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CONRAD Clinical Research Center, Eastern Virginia Medical School

Authority:

United States: Food and Drug Administration

Study ID:

R01HD43175

NCT ID:

NCT00064766

Start Date:

February 2003

Completion Date:

February 2005

Related Keywords:

  • Endometrial Bleeding
  • Periodontal Disease
  • Norplant
  • Periodontal disease
  • Endometrial bleeding
  • Progestin-induced endometrial bleeding
  • Hemorrhage
  • Periodontal Diseases
  • Adenoma
  • Uterine Hemorrhage

Name

Location

CONRAD Clinical Research Center, Eastern Virginia Medical SchoolNorfolk, Virginia  23507