Study of a COX-2 Inhibitor for Prevention of Ovulation

Instituto Chileno de Medicina Reproductiva

Status and phase: Unknown; Phase 2

Conditions: Rupture; Graafian Follicle

Treatments: Drug: Meloxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT01346137

CIG-10-131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 1 patient group

meloxicam

Experimental group

Description:

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

Treatment:

Drug: Meloxicam