Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cycle | No Intervention | Control menstrual cycle | |
| Pre-LH surge celecoxib administration | Experimental | Pre-LH surge dosing of celecoxib |
|
| Post-LH surge celecoxib administration | Experimental | Post-LH surge dosing of celecoxib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celebrex | Drug | 400 mg PO daily intermittently based on hormone and ultrasound findings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase | One cycle corresponds to one participant | 4 cycles (approximately 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 cycles (approximately 4 months) |
| Peak Estradiol Level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22902348 | Result | 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. |
| Label | URL |
|---|---|
| Author Manuscript | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control Cycle (no Celecoxib or Placebo) |
| |||||||||||||
| Treatment Cycle 1 |
| |||||||||||||
| Washout Cycle |
| |||||||||||||
| Treatment Cycle 2 |
|
healthy reproductive-aged women with regular cycles, not currently using or needing hormonal contraception
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PreLH/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. |
| BG001 | PostLH/preLH |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase | 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. | Posted | Count of Participants | Participants | 4 cycles (approximately 4 months) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Cycle | Monitoring through ovarian ultrasound and serum hormone levels of menstrual cycle prior to receiving any study treatment in order to insure ovulatory activity. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Edelman | Oregon Health and Science University | 503-494-5949 | edelmana@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo identical to celecoxib |
|
Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle.
| 4 cycles (approximately 4 months) |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Post-LH Surge Celecoxib | 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 |
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 4 cycles (approximately 4 months) |
|
|
|
| Secondary | Peak Estradiol Level | Average serum levels of estradiol (pg/mL) normalized to days of the luteal phase of menstrual cycle. | 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. | Posted | Mean | Standard Deviation | pg/mL | 4 cycles (approximately 4 months) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Pre-LH Celecoxib | Received 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Post-LH Surge Celecoxib | 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 | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|