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

    Phase 2
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    meloxicam ...
  • Study Participants

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.
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 Started
Jan 31
Primary Completion
Apr 30
Study Completion
Sep 30
Last Update
May 03

Drug Meloxicam

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

meloxicam Experimental

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


Inclusion Criteria:

Proven fertility in the past
18- 40 years old
Regular menstrual cycles in the past 3 months (24-35 days)
Surgically sterilized
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
No Results Posted