Trial Outcomes & Findings for The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle (NCT NCT00614406)

NCT ID: NCT00614406

Last Updated: 2012-12-13

Results Overview

Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-12-13

Participant Flow

Potential subjects may also have learned about the study from an OHSU Center for Women's Health provider.Visit 1: reviewed of medical history and demographics and vital signs. A blood draw and urine pregnancy test was performed. Eligible subjects returned for the enrollment.

Participant milestones

Measure	Active Drug Cycle Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle	Placebo Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
Overall Study STARTED	7	4
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle

Baseline characteristics by cohort

Measure	Active Drug Cycle n=7 Participants Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle	Placebo n=4 Participants Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle	Total n=11 Participants Total of all reporting groups
Age Continuous	27.3 years STANDARD_DEVIATION 5.2 • n=5 Participants	28.8 years STANDARD_DEVIATION 6.1 • n=7 Participants	27.85 years STANDARD_DEVIATION 0.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intention to Treat (ITT)

Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry.

Outcome measures

Measure	Active Drug n=7 Participants Active drug(celecoxib 400 mg orally, daily for 1 menstrual cycle) cycle \[cycle = length of menstrual cycle\]	Placebo n=4 Participants Placebo cycle orally, daily x1 menstrual cycle \[cycle = length of menstrual cycle\]
Menstrual Cycle Length	28.5 Days Standard Deviation 2.5	27.2 Days Standard Deviation 2.4

Adverse Events

Active Drug Cycle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison Edelman, MD, MPH

Oregon Health and Sciences University

Phone: 503-494-5949

Email: edelmana@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place