NCT01129245

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 2, 2014

Completed
Last Updated

June 18, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 21, 2010

Results QC Date

April 7, 2014

Last Update Submit

May 24, 2019

Conditions

OvulationLuteal Development

Keywords

Celebrexprostoglandin inhibitorovulationemergency contraception

Outcome Measures

Primary Outcomes (1)

  • Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase

    One cycle corresponds to one participant

    4 cycles (approximately 4 months)

Secondary Outcomes (2)

  • Peak Hormone Levels

    4 cycles (approximately 4 months)

  • Peak Estradiol Level

    4 cycles (approximately 4 months)

Study Arms (3)

Control cycle

NO INTERVENTION

Control menstrual cycle

Pre-LH surge celecoxib administration

EXPERIMENTAL

Pre-LH surge dosing of celecoxib

Drug: CelebrexDrug: Placebo

Post-LH surge celecoxib administration

EXPERIMENTAL

Post-LH surge dosing of celecoxib

Drug: CelebrexDrug: Placebo

Interventions

CelebrexDRUG

400 mg PO daily intermittently based on hormone and ultrasound findings

Also known as: Celecoxib
Post-LH surge celecoxib administrationPre-LH surge celecoxib administration
PlaceboDRUG

Placebo identical to celecoxib

Post-LH surge celecoxib administrationPre-LH surge celecoxib administration

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 22902348RESULT

Related Links

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Alison Edelman
Organization
Oregon Health and Science University
edelmana@ohsu.edu
503-494-5949

Study Officials

  • Alison Edelman, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor SM.OB/GYN Generalist Division

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 24, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 18, 2019

Results First Posted

July 2, 2014

Record last verified: 2019-05

Locations

US(1)