Study of a COX-2 Inhibitor for Prevention of Ovulation

NCT01346137 | Unknown Phase 2 DMC

• 1 other identifier: CIG-10-131
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture; Graafian Follicle

Keywords

ovulation; unruptured luteinized follicle; meloxicam

Outcome Measures

Primary Outcomes (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.

  To assess follicular outcomes transvaginal ultrasound will be done to all participants during treatment cycles

  3 menstrual cycles treated (3 months)

Secondary Outcomes (7)

• Occurrence of functioning corpus luteum subsequent to unruptured follicles

  3 menstrual cycles treated (3 months)

• Bleeding pattern during treatment with meloxicam

  3 menstrual cycles treated (3 months)

• Incidence of adverse events

  3 menstrual cycles treated (3 months)

• Pharmacokinetics of meloxicam

  1 menstrual cycle (1 month)

• Levels of estradiol

  3 menstrual cycles treated (3 months)

Study Arms (1)

meloxicam

EXPERIMENTAL

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

Drug: Meloxicam

Interventions

Meloxicam DRUG

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

meloxicam

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Proven fertility in the past
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Chileno de Medicina Reproductiva: lead
• CONRAD: collaborator

Study Sites (1)

Instituto Chileno de Medicina Reproductiva (ICMER)

Santiago, Chile

RECRUITING

Related Publications (3)

• 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.

  PMID: 19933235 BACKGROUND

• 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.

  PMID: 16855077 BACKGROUND

• 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.

  PMID: 24909636 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Rupture

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cristián Jesam, MD

  Instituto Chileno de Medicina Reproductiva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana M Salvatierra, Rs. Midwife

CONTACT

+5626324644; amsalvatie@icmer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: May 2, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 3, 2011

Record last verified: 2011-03

Locations

CL (1)