Rupture; Graafian Follicle Clinical Trial
Official title:
An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation
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.
| Status | Unknown status |
| Enrollment | 56 |
| Est. completion date | September 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Chile | Instituto Chileno de Medicina Reproductiva (ICMER) | Santiago |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Chileno de Medicina Reproductiva | CONRAD |
Chile,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Occurrence of functioning corpus luteum subsequent to unruptured follicles | 3 menstrual cycles treated (3 months) | ||
| Secondary | Bleeding pattern during treatment with meloxicam | 3 menstrual cycles treated (3 months) | ||
| Secondary | Incidence of adverse events | In all cycles adverse events will be evaluated with a questionnaire performed in all visits | 3 menstrual cycles treated (3 months) | |
| Secondary | 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 | 1 menstrual cycle (1 month) | |
| Secondary | Levels of estradiol | 3 menstrual cycles treated (3 months) | ||
| Secondary | Levels of progesterone | 3 menstrual cycles (3 months) | ||
| Secondary | Levels of LH | 3 menstrual cycles (3 months) |