Trial Outcomes & Findings for The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation (NCT NCT01129245)
NCT ID: NCT01129245
Last Updated: 2019-06-18
Results Overview
One cycle corresponds to one participant
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
4 cycles (approximately 4 months)
Results posted on
2019-06-18
Participant Flow
Participant milestones
| Measure |
PreLH Followed by postLH
Control cycle First, preLH surge dosing of celecoxib and postLH surge dosing of placebo. Followed by, preLH surge dosing of placebo and postLH surge dosing of drug.
|
PostLH Followed by preLH
Control cycle First, postLH surge dosing of celecoxib and preLH surge dosing of placebo. Followed by, postLH surge dosing of placebo and preLH surge dosing of drug.
|
|---|---|---|
|
Control Cycle (no Celecoxib or Placebo)
STARTED
|
10
|
10
|
|
Control Cycle (no Celecoxib or Placebo)
COMPLETED
|
10
|
10
|
|
Control Cycle (no Celecoxib or Placebo)
NOT COMPLETED
|
0
|
0
|
|
Treatment Cycle 1
STARTED
|
10
|
10
|
|
Treatment Cycle 1
COMPLETED
|
10
|
10
|
|
Treatment Cycle 1
NOT COMPLETED
|
0
|
0
|
|
Washout Cycle
STARTED
|
10
|
10
|
|
Washout Cycle
COMPLETED
|
10
|
10
|
|
Washout Cycle
NOT COMPLETED
|
0
|
0
|
|
Treatment Cycle 2
STARTED
|
10
|
10
|
|
Treatment Cycle 2
COMPLETED
|
10
|
10
|
|
Treatment Cycle 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Baseline characteristics by cohort
| Measure |
PreLH/postLH
n=10 Participants
Control cycle First, preLH surge dosing of celecoxib and postLH surge dosing of placebo. Followed by, preLH surge dosing of placebo and postLH surge dosing of drug.
|
PostLH/preLH
n=10 Participants
Control cycle First, postLH surge dosing of celecoxib and preLH surge dosing of placebo. Followed by, postLH surge dosing of placebo and preLH surge dosing of drug.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.2 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic, Caucasian
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 cycles (approximately 4 months)Population: Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.
One cycle corresponds to one participant
Outcome measures
| Measure |
Control Cycle
n=20 Participants
Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
|
Pre-LH Celecoxib
n=20 Participants
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results
Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
|
Post-LH Surge Celecoxib
n=20 Participants
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.
Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
|
|---|---|---|---|
|
Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase
|
1 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 cycles (approximately 4 months)Population: One cycle corresponds to one participant. Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.
Average serum levels of progesterone (ng/mL) and luteinizing hormone (ng/mL) normalized to days of the luteal phase of menstrual cycle.
Outcome measures
| Measure |
Control Cycle
n=20 Participants
Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
|
Pre-LH Celecoxib
n=20 Participants
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results
Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
|
Post-LH Surge Celecoxib
n=20 Participants
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.
Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
|
|---|---|---|---|
|
Peak Hormone Levels
LH (luteinizing hormone)
|
39.7 ng/mL
Standard Deviation 25
|
46.2 ng/mL
Standard Deviation 28.4
|
42.6 ng/mL
Standard Deviation 22.2
|
|
Peak Hormone Levels
P (progesterone)
|
13.3 ng/mL
Standard Deviation 3.3
|
13.5 ng/mL
Standard Deviation 3.9
|
12.3 ng/mL
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 4 cycles (approximately 4 months)Population: One cycle corresponds to one participant. Placebo treatment was not analyzed. This cycle was purely included in the study flow to keep investigators blinded to treatment allocation. It was pre-specified that it would not be analyzed.
Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.
Outcome measures
| Measure |
Control Cycle
n=20 Participants
Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity.
|
Pre-LH Celecoxib
n=20 Participants
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results
Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
|
Post-LH Surge Celecoxib
n=20 Participants
Receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results.
Celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings
|
|---|---|---|---|
|
Peak Estradiol Level
|
274 pg/mL
Standard Deviation 99.6
|
289.4 pg/mL
Standard Deviation 124.5
|
282.2 pg/mL
Standard Deviation 106.7
|
Adverse Events
Control Cycle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-LH Celecoxib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-LH Surge Celecoxib
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place