Study of a COX-2 Inhibitor for Prevention of Ovulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346137
Recruitment Status : Unknown
Verified March 2011 by Instituto Chileno de Medicina Reproductiva.
Recruitment status was:  Recruiting
First Posted : May 2, 2011
Last Update Posted : May 3, 2011
Information provided by:
Instituto Chileno de Medicina Reproductiva

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rupture; Graafian Follicle Drug: Meloxicam Phase 2

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  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation
Study Start Date : January 2011
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Occurrence of functioning corpus luteum subsequent to unruptured follicles [ Time Frame: 3 menstrual cycles treated (3 months) ]
  2. Bleeding pattern during treatment with meloxicam [ Time Frame: 3 menstrual cycles treated (3 months) ]
  3. 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

  4. 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

  5. Levels of estradiol [ Time Frame: 3 menstrual cycles treated (3 months) ]
  6. Levels of progesterone [ Time Frame: 3 menstrual cycles (3 months) ]
  7. Levels of LH [ Time Frame: 3 menstrual cycles (3 months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01346137

Contact: Ana M Salvatierra, Rs. Midwife +5626324644

Instituto Chileno de Medicina Reproductiva (ICMER) Recruiting
Santiago, Chile
Contact: Ana M Salvatierra, Rs. Midwife   
Principal Investigator: Cristián Jesam, MD         
Sponsors and Collaborators
Instituto Chileno de Medicina Reproductiva
Principal Investigator: Cristián Jesam, MD Instituto Chileno de Medicina Reproductiva

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cristián Jesam Gaete, ICMER Identifier: NCT01346137     History of Changes
Other Study ID Numbers: CIG-10-131
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: March 2011

Keywords provided by Instituto Chileno de Medicina Reproductiva:
unruptured luteinized follicle

Additional relevant MeSH terms:
Wounds and Injuries
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action