The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
1 other identifier
interventional
11
1 country
1
Brief Summary
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
July 4, 2012
CompletedDecember 13, 2012
December 1, 2012
7 months
January 31, 2008
July 15, 2011
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Menstrual Cycle Length
Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.
3 months
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Cardiac disease or hypertension
- Moderate to severe heartburn (GERD)
- Obesity (BMI greater than 30)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Society of Family Planningcollaborator
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allison Edelman, MD, MPH
- Organization
- Oregon Health and Sciences University
Study Officials
- PRINCIPAL INVESTIGATOR
Alison Edelman, MD, MPH
Oregon Health and Science University
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
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MPH
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 13, 2008
Study Start
January 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
December 13, 2012
Results First Posted
July 4, 2012
Record last verified: 2012-12