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| Name | Class |
|---|---|
| CONRAD | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meloxicam | Experimental | 15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug | 15 mg versus 30 mg per day P.O. for 15 days during 3 menstrual cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana M Salvatierra, Rs. Midwife | Contact | +5626324644 | amsalvatie@icmer.org |
| Name | Affiliation | Role |
|---|---|---|
| Cristián Jesam, MD | Instituto Chileno de Medicina Reproductiva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Chileno de Medicina Reproductiva (ICMER) | Recruiting | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19933235 | Background | 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. | |
| 16855077 | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 3, 2013 | |
| Reset | May 21, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 3, 2013 | May 21, 2013 |
| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| 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) |
| 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) |
| Levels of estradiol | 3 menstrual cycles treated (3 months) |
| Levels of progesterone | 3 menstrual cycles (3 months) |
| Levels of LH | 3 menstrual cycles (3 months) |
| 24909636 | Derived | 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. |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |