OvulationNCT01129245
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
A study testing Celebrex in people with Ovulation and Luteal Development, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation. 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, Luteal Development
- What is being tested?
- Celebrex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- 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
- Currently NOT using hormonal contraception
- Cycle length between 26-34 days
- General good health (specifically no hx of: diabetes, cardiac problems, moderate/severe heart burn (GERD), obesity (BMI > 30), hypertension (BP > 130/80)
- Willing and able to agree to randomization and informed consent
- Willing and able to use a menstrual diary to chart bleeding Serum progesterone > 3 ng/ml (from cycle day 18-25)
- Willing and able to return to clinic for bi-weekly for blood tests and ultrasounds throughout cycles 2, 3 \& 5
Who cannot join
- Diabetes
- Cardiac disease
- Moderate to severe heart burn (or GERD) Obesity (BMI > 30) Hypertension (BP > 130/80)
- Allergy to NSAIDS
- Currently pregnant or trying to conceive
- Polycystic Ovarian Syndrome
- Use of hormonal contraception (participants can use barrier methods, spermicide, female or male sterilization, copper intrauterine device, abstinence, or have female partners
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.
Read the detailed description
A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.
This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.
- Conditions
- Ovulation, Luteal Development
- Being tested
- Celebrex, Placebo
- Keywords
- Celebrex, prostoglandin inhibitor, ovulation, emergency contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelebrexDrug
Also called Celecoxib
400 mg PO daily intermittently based on hormone and ultrasound findings
PlaceboDrug
Placebo identical to celecoxib
| Study group | Role | What they receive |
|---|---|---|
| Control cycle | No intervention | Control menstrual cycle |
| Pre-LH surge celecoxib administration | Experimental | Pre-LH surge dosing of celecoxib Receives: Drug: Celebrex; Drug: Placebo |
| Post-LH surge celecoxib administration | Experimental | Post-LH surge dosing of celecoxib Receives: Drug: Celebrex; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
One cycle corresponds to one participant
Measured: 4 cycles (approximately 4 months)
Secondary outcomes (2)
Peak Hormone Levels
Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.
Measured: 4 cycles (approximately 4 months)
Peak Estradiol Level
Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.
Measured: 4 cycles (approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OvulationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT01129245
- Sponsor's protocol ID
- OHSU FAMPLAN SFP3-7
- Status last verified
- May 2019
- First submitted
- 21 May 2010
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Edelman AB, Jensen JT, Doom C, Hennebold JD. Impact of the prostaglandin synthase-2 inhibitor celecoxib on ovulation and luteal events in women. Contraception. 2013 Mar;87(3):352-7. doi: 10.1016/j.contraception.2012.07.004. Epub 2012 Aug 16.
PubMed 22902348
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
- ClinicalTrials.gov ID
- NCT01129245
- Acronym / sponsor ID
- OHSU FAMPLAN SFP3-7
- Conditions
- Ovulation, Luteal Development
- Keywords
- Celebrex, prostoglandin inhibitor, ovulation, emergency contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.
Detailed description
A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.
This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control cycle | No intervention | –Control menstrual cycle |
| Pre-LH surge celecoxib administration | Experimental | Drug: Celebrex, Drug: PlaceboPre-LH surge dosing of celecoxib |
| Post-LH surge celecoxib administration | Experimental | Drug: Celebrex, Drug: PlaceboPost-LH surge dosing of celecoxib |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-35
- Currently NOT using hormonal contraception
- Cycle length between 26-34 days
- General good health (specifically no hx of: diabetes, cardiac problems, moderate/severe heart burn (GERD), obesity (BMI > 30), hypertension (BP > 130/80)
- Willing and able to agree to randomization and informed consent
Key exclusion criteria (7 listed)
- Diabetes
- Cardiac disease
- Moderate to severe heart burn (or GERD) Obesity (BMI > 30) Hypertension (BP > 130/80)
- Allergy to NSAIDS
- Currently pregnant or trying to conceive
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 |
|---|---|---|
| CelebrexAlso: Celecoxib400 mg PO daily intermittently based on hormone and ultrasound findings | Drug | Post-LH surge celecoxib administration, Pre-LH surge celecoxib administration |
| PlaceboPlacebo identical to celecoxib | Drug | Post-LH surge celecoxib administration, Pre-LH surge celecoxib administration |
Primary outcome
Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
Time frame: 4 cycles (approximately 4 months)
One cycle corresponds to one participant
2 secondary outcomes
Peak Hormone Levels
Time frame: 4 cycles (approximately 4 months)
Peak Estradiol Level
Time frame: 4 cycles (approximately 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22902348Edelman AB, Jensen JT, Doom C, Hennebold JD. Impact of the prostaglandin synthase-2 inhibitor celecoxib on ovulation and luteal events in women. Contraception. 2013 Mar;87(3):352-7. doi: 10.1016/j.contraception.2012.07.004. Epub 2012 Aug 16.
- Author ManuscriptLink provided by the sponsor.
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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 and Luteal Development, 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 7 inclusion and 7 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 18 Jun 2019. 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. 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 2 Jul 2014). 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?
Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase (time frame: 4 cycles (approximately 4 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 NCT01129245, which also lists 1 linked publication.
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 18 Jun 2019.