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Study of a COX-2 Inhibitor for Prevention of Ovulation

Primary Purpose

Rupture; Graafian Follicle

Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Meloxicam
Sponsored by
Instituto Chileno de Medicina Reproductiva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rupture; Graafian Follicle focused on measuring ovulation, unruptured luteinized follicle, meloxicam

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Chileno de Medicina Reproductiva (ICMER)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

meloxicam

Arm Description

15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles

Outcomes

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.
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
Bleeding pattern during treatment with meloxicam
Incidence of adverse events
In all cycles adverse events will be evaluated with a questionnaire performed in all visits
Pharmacokinetics of meloxicam
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
Levels of progesterone
Levels of LH

Full Information

First Posted
April 19, 2011
Last Updated
May 2, 2011
Sponsor
Instituto Chileno de Medicina Reproductiva
Collaborators
CONRAD
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1. Study Identification

Unique Protocol Identification Number
NCT01346137
Brief Title
Study of a COX-2 Inhibitor for Prevention of Ovulation
Official Title
An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Chileno de Medicina Reproductiva
Collaborators
CONRAD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture; Graafian Follicle
Keywords
ovulation, unruptured luteinized follicle, meloxicam

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
meloxicam
Arm Type
Experimental
Arm Description
15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Description
15 mg versus 30 mg per day P.O. for 15 days during 3 menstrual cycles
Primary Outcome Measure Information:
Title
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.
Description
To assess follicular outcomes transvaginal ultrasound will be done to all participants during treatment cycles
Time Frame
3 menstrual cycles treated (3 months)
Secondary Outcome Measure Information:
Title
Occurrence of functioning corpus luteum subsequent to unruptured follicles
Time Frame
3 menstrual cycles treated (3 months)
Title
Bleeding pattern during treatment with meloxicam
Time Frame
3 menstrual cycles treated (3 months)
Title
Incidence of adverse events
Description
In all cycles adverse events will be evaluated with a questionnaire performed in all visits
Time Frame
3 menstrual cycles treated (3 months)
Title
Pharmacokinetics of meloxicam
Description
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
Time Frame
1 menstrual cycle (1 month)
Title
Levels of estradiol
Time Frame
3 menstrual cycles treated (3 months)
Title
Levels of progesterone
Time Frame
3 menstrual cycles (3 months)
Title
Levels of LH
Time Frame
3 menstrual cycles (3 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana M Salvatierra, Rs. Midwife
Phone
+5626324644
Email
amsalvatie@icmer.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristián Jesam, MD
Organizational Affiliation
Instituto Chileno de Medicina Reproductiva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Chileno de Medicina Reproductiva (ICMER)
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana M Salvatierra, Rs. Midwife
Email
amsalvatie@icmer.org
First Name & Middle Initial & Last Name & Degree
Cristián Jesam, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19933235
Citation
Jesam C, Salvatierra AM, Schwartz JL, Croxatto HB. Suppression of follicular rupture with meloxicam, a cyclooxygenase-2 inhibitor: potential for emergency contraception. Hum Reprod. 2010 Feb;25(2):368-73. doi: 10.1093/humrep/dep392. Epub 2009 Nov 19.
Results Reference
background
PubMed Identifier
16855077
Citation
Bata MS, Al-Ramahi M, Salhab AS, Gharaibeh MN, Schwartz J. Delay of ovulation by meloxicam in healthy cycling volunteers: A placebo-controlled, double-blind, crossover study. J Clin Pharmacol. 2006 Aug;46(8):925-32. doi: 10.1177/0091270006289483.
Results Reference
background
PubMed Identifier
24909636
Citation
Jesam C, Salvatierra AM, Schwartz JL, Fuentes A, Croxatto HB. Effect of oral administration of a continuous 18 day regimen of meloxicam on ovulation: experience of a randomized controlled trial. Contraception. 2014 Aug;90(2):168-73. doi: 10.1016/j.contraception.2014.04.011. Epub 2014 May 5.
Results Reference
derived
Links:
URL
http://www.icmer.org
Description
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Study of a COX-2 Inhibitor for Prevention of Ovulation

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