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Study of a COX-2 Inhibitor for Prevention of Ovulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Instituto Chileno de Medicina Reproductiva.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
CONRAD
Information provided by:
Instituto Chileno de Medicina Reproductiva
ClinicalTrials.gov Identifier:
NCT01346137
First received: April 19, 2011
Last updated: May 2, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Rupture; Graafian Follicle
 Drug: Meloxicam
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation

Resource links provided by NLM:

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

Further study details as provided by Instituto Chileno de Medicina Reproductiva:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    To assess follicular outcomes transvaginal ultrasound will be done to all participants during treatment cycles


Secondary Outcome Measures:
  • Occurrence of functioning corpus luteum subsequent to unruptured follicles [ Time Frame: 3 menstrual cycles treated (3 months) ] [ Designated as safety issue: No ]
  • Bleeding pattern during treatment with meloxicam [ Time Frame: 3 menstrual cycles treated (3 months) ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 3 menstrual cycles treated (3 months) ] [ Designated as safety issue: Yes ]
    In all cycles adverse events will be evaluated with a questionnaire performed in all visits

  • Pharmacokinetics of meloxicam [ Time Frame: 1 menstrual cycle (1 month) ] [ Designated as safety issue: No ]
    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

  • Levels of estradiol [ Time Frame: 3 menstrual cycles treated (3 months) ] [ Designated as safety issue: No ]
  • Levels of progesterone [ Time Frame: 3 menstrual cycles (3 months) ] [ Designated as safety issue: No ]
  • Levels of LH [ Time Frame: 3 menstrual cycles (3 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: January 2011
Estimated Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: meloxicam

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346137

Contacts
Contact: Ana M Salvatierra, Rs. Midwife +5626324644 amsalvatie@icmer.org

Locations
Chile
Instituto Chileno de Medicina Reproductiva (ICMER) Recruiting
Santiago, Chile
Contact: Ana M Salvatierra, Rs. Midwife         amsalvatie@icmer.org    
Principal Investigator: Cristián Jesam, MD            
Sponsors and Collaborators
Instituto Chileno de Medicina Reproductiva
CONRAD
Investigators
Principal Investigator: Cristián Jesam, MD Instituto Chileno de Medicina Reproductiva
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Cristián Jesam Gaete, ICMER
ClinicalTrials.gov Identifier: NCT01346137     History of Changes
Other Study ID Numbers: CIG-10-131
Study First Received: April 19, 2011
Last Updated: May 2, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013