Ovulation (Follicular Rupture Yes/no)NCT00614406
The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
A study testing Celebrex in people with Ovulation (Follicular Rupture Yes/no) and Menstrual Cycles (Total Length, Bleeding Days), run by Oregon Health and Science University at 1 site in United States.
Trial summary
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation (Follicular Rupture Yes/no), Menstrual Cycles (Total Length, Bleeding Days), Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
- What is being tested?
- Celebrex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35
- Normal menstrual periods (24-35 days)
- Good general health
- Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
- Willing and able to return to clinic for bi-weekly blood tests
Who cannot join
- Pregnant or breast feeding
- Polycystic ovarian disease
- Gastrointestinal conditions (i.e.gastric ulcer)
- Currently using birth control
- Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs
- Diabetes
Show all 9Show fewer
- Cardiac disease or hypertension
- Moderate to severe heartburn (GERD)
- Obesity (BMI greater than 30)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Read the detailed description
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.
- Conditions
- Ovulation (Follicular Rupture Yes/no), Menstrual Cycles (Total Length, Bleeding Days), Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
- Being tested
- Celebrex, Placebo
- Keywords
- Celebrex, prostaglandin inhibitor, ovulation, menstrual cycles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelebrexDrug
One 400mg tablet daily.
PlaceboDrug
One tablet daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Celebrex |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Cycle Length
Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovulation (Follicular Rupture Yes/no)Studies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Alison Edelman, Oregon Health and Science University
- Investigators
- Alison Edelman, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614406
- Sponsor's protocol ID
- OHSU FAMPLAN 3854
- Status last verified
- Dec 2012
- First submitted
- 31 Jan 2008
- Last updated
- 13 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle.
- ClinicalTrials.gov ID
- NCT00614406
- Acronym / sponsor ID
- OHSU FAMPLAN 3854
- Conditions
- Ovulation (Follicular Rupture Yes/no), Menstrual Cycles (Total Length, Bleeding Days), Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
- Keywords
- Celebrex, prostaglandin inhibitor, ovulation, menstrual cycles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 4 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Detailed description
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Celebrex |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-35
- Normal menstrual periods (24-35 days)
- Good general health
- Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence)
- Willing and able to return to clinic for bi-weekly blood tests
Key exclusion criteria (9 listed)
- Pregnant or breast feeding
- Polycystic ovarian disease
- Gastrointestinal conditions (i.e.gastric ulcer)
- Currently using birth control
- Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs
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 |
|---|---|---|
| CelebrexOne 400mg tablet daily. | Drug | 1 |
| PlaceboOne tablet daily. | Drug | 2 |
Primary outcome
Menstrual Cycle Length
Time frame: 3 months
Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- OHSU Women's Health Research UnitLink 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.
Alison Edelman, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celebrex in people with Ovulation (Follicular Rupture Yes/no) and Menstrual Cycles (Total Length, Bleeding Days), run by Oregon Health and Science University at 1 site in United States.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 13 Dec 2012. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Cycle Length (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2012.