Rupture; Graafian FolliclePhase 2NCT01346137
Study of a COX-2 Inhibitor for Prevention of Ovulation
A Phase 2 study testing Meloxicam in people with Rupture; Graafian Follicle, run by Instituto Chileno de Medicina Reproductiva at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rupture; Graafian Follicle
- What is being tested?
- Meloxicam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChile
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Instituto Chileno de Medicina Reproductiva (ICMER)
Santiago
Ana M Salvatierra, Rs. Midwife, amsalvatie@icmer.org
Cristián Jesam, MD
About this study
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.
Read the detailed 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.
- Conditions
- Rupture; Graafian Follicle
- Being tested
- Meloxicam
- Keywords
- ovulation, unruptured luteinized follicle, meloxicam
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
15 mg versus 30 mg per day P.O. for 15 days during 3 menstrual cycles
| Study group | Role | What they receive |
|---|---|---|
| meloxicam | Experimental | 15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles Receives: Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 menstrual cycles treated (3 months)
Secondary outcomes (7)
Occurrence of functioning corpus luteum subsequent to unruptured follicles
Measured: 3 menstrual cycles treated (3 months)
Bleeding pattern during treatment with meloxicam
Measured: 3 menstrual cycles treated (3 months)
Incidence of adverse events
In all cycles adverse events will be evaluated with a questionnaire performed in all visits
Measured: 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
Measured: 1 menstrual cycle (1 month)
Levels of estradiol
Measured: 3 menstrual cycles treated (3 months)
Levels of progesterone
Measured: 3 menstrual cycles (3 months)
Levels of LH
Measured: 3 menstrual cycles (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rupture; Graafian FollicleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Chileno de Medicina Reproductiva
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD
- Investigators
- Cristián Jesam, MD, Principal investigator, Instituto Chileno de Medicina Reproductiva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346137
- Sponsor's protocol ID
- CIG-10-131
- Status last verified
- Mar 2011
- First submitted
- 19 Apr 2011
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19933235Bata 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.
PubMed 16855077Jesam 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.
PubMed 24909636
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of a COX-2 Inhibitor(Meloxicam) for Prevention of Ovulation
- ClinicalTrials.gov ID
- NCT01346137
- Acronym / sponsor ID
- CIG-10-131
- Conditions
- Rupture; Graafian Follicle
- Keywords
- ovulation, unruptured luteinized follicle, meloxicam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Instituto Chileno de Medicina ReproductivaUniversity, hospital or other
- Collaborators
- CONRAD
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| meloxicam | Experimental | Drug: Meloxicam15 mg versus 30 mg per day P.O for 15 days, during 3 menstrual cycles |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy
- Proven fertility in the past
- 18- 40 years old
- Regular menstrual cycles in the past 3 months (24-35 days)
- Surgically sterilized
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meloxicam15 mg versus 30 mg per day P.O. for 15 days during 3 menstrual cycles | Drug | meloxicam |
Primary outcome
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.
Time frame: 3 menstrual cycles treated (3 months)
To assess follicular outcomes transvaginal ultrasound will be done to all participants during treatment cycles
7 secondary outcomes
Occurrence of functioning corpus luteum subsequent to unruptured follicles
Time frame: 3 menstrual cycles treated (3 months)
Bleeding pattern during treatment with meloxicam
Time frame: 3 menstrual cycles treated (3 months)
Incidence of adverse events
Time frame: 3 menstrual cycles treated (3 months)
Pharmacokinetics of meloxicam
Time frame: 1 menstrual cycle (1 month)
Levels of estradiol
Time frame: 3 menstrual cycles treated (3 months)
Levels of progesterone
Time frame: 3 menstrual cycles (3 months)
Levels of LH
Time frame: 3 menstrual cycles (3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
- Background: PubMed 19933235Jesam 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.
- Background: PubMed 16855077Bata 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.
- Derived from this study: PubMed 24909636Jesam 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristián Jesam, MD principal investigator
Instituto Chileno de Medicina Reproductiva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meloxicam in people with Rupture; Graafian Follicle, run by Instituto Chileno de Medicina Reproductiva at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana M Salvatierra, Rs. Midwife (+5626324644, amsalvatie@icmer.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 menstrual cycles treated (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346137, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2011.