Study of a COX-2 Inhibitor for Prevention of Ovulation

May 2, 2011 updated by: Instituto Chileno de Medicina Reproductiva

An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation

In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess its effect on follicular development and find out if this regimen delays or blocks ovulation while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg of meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous cycles. The 3 treatment cycles will be preceded and followed by control cycles with no treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in multiple blood samples in each cycle. The investigators will recruit a total of 56 women. Each woman will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to each of the 2 dose regimens. Participating women will demonstrate an ovulatory cycle before starting meloxicam treatment and will be protected from pregnancy by prior sterilization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In a recent study, following follicular development by daily ultrasound examinations in 22 women, meloxicam was administered when the dominant follicle reached a diameter of 18 mm (Jesam, Salvatierra et al. 2010). Results from this study indicate that meloxicam 30 mg given for five days in late follicular phase was more effective at delaying follicular rupture than 15 mg. Follicular rupture was delayed more than 48 hours in 11/22 (50%) volunteers in the group treated with 15 mg/day and in 20/22 (91%) volunteers in the group treated with 30 mg/day.

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Instituto Chileno De Medicina Reproductiva (ICMER)
        • Contact:
        • Principal Investigator:
          • Cristián Jesam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy
  • Proven fertility in the past
  • 18- 40 years old
  • Regular menstrual cycles in the past 3 months (24-35 days)
  • Surgically sterilized
  • Non-lactating
  • Hemoglobin of at least 11 g/dl
  • Willing to give informed consent in writing

Exclusion Criteria:

  • Allergy to meloxicam, aspirin, or other NSAIDs
  • Currently pregnant or breast feeding
  • History of gastrointestinal problems like stomach ulcer, bleeding or bowel problems
  • History of heart attack, stroke, or blood clot
  • Hemorrhagic or coagulation disorders
  • Known liver and renal disorder
  • History of or signs and symptoms of cancer, hyperprolactinemia, bloody breast discharge, diabetes, or any endocrine disturbance
  • History of asthma, skin or mucosal allergies
  • Hypertension: systolic blood pressure > 135 mm Hg or diastolic blood pressure >85 mmHg
  • History of mental illness including depression or epilepsy
  • Cigarette smoker
  • Habitual user of anti-inflammatory drugs
  • Alcoholism or any drug abuse
  • Use of anticoagulants or steroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: meloxicam
15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles
Drug: Meloxicam
15 mg versus 30 mg per day P.O. for 15 days during 3 menstrual cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the efficacy of meloxicam in preventing ovulation as measured by ovarian follicular development and delay in rupture when is administered daily for 18 days, starting on the 5th day of the cycle.
Time Frame: 3 menstrual cycles treated (3 months)
To assess follicular outcomes transvaginal ultrasound will be done to all participants during treatment cycles
3 menstrual cycles treated (3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of functioning corpus luteum subsequent to unruptured follicles
Time Frame: 3 menstrual cycles treated (3 months)
3 menstrual cycles treated (3 months)
Bleeding pattern during treatment with meloxicam
Time Frame: 3 menstrual cycles treated (3 months)
3 menstrual cycles treated (3 months)
Incidence of adverse events
Time Frame: 3 menstrual cycles treated (3 months)
In all cycles adverse events will be evaluated with a questionnaire performed in all visits
3 menstrual cycles treated (3 months)
Pharmacokinetics of meloxicam
Time Frame: 1 menstrual cycle (1 month)
During the first treatment cycle, plasma levels of meloxicam will be measured in all participants to evaluate levels obtained with the administration of the drug for 15 consecutive days. Levels of the drug will be correlate with follicular outcomes
1 menstrual cycle (1 month)
Levels of estradiol
Time Frame: 3 menstrual cycles treated (3 months)
3 menstrual cycles treated (3 months)
Levels of progesterone
Time Frame: 3 menstrual cycles (3 months)
3 menstrual cycles (3 months)
Levels of LH
Time Frame: 3 menstrual cycles (3 months)
3 menstrual cycles (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Chileno de Medicina Reproductiva

Collaborators

CONRAD

Investigators

  • Principal Investigator: Cristián Jesam, MD, Instituto Chileno de Medicina Reproductiva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

April 19, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (ESTIMATE)

May 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2011

Last Update Submitted That Met QC Criteria

May 2, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIG-10-131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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