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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed emergency contraceptives. Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. More data is needed regarding emergency contraception containing ulipristal acetate. The overall project will be focused on both levonorgestrel (LNG) - and ulipristal acetate (UPA)-containing emergency contraception but this protocol registration is for the UPA aspect of the study procedures.
Emergency contraception (EC) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. Orally-dosed EC works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. Unfortunately, obese women are significantly more likely than their normal BMI counterparts to experience failure of orally-dosed EC and in some instances EC is equivalent to placebo.
Our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed EC in obese women. We hypothesize that increasing the dose of orally-dosed EC agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. In the overall proposal, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of UPA-based EC in obese women and expand upon our preliminary findings of LNG-based EC. This protocol registration is for the UPA aspect of the study procedures focused on the pharmacokinetics and pharmacodynamics of UPA and will include a dose escalation intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UPA-ECx1 followed by ECx2 | Active Comparator | Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements. |
|
| UPA-ECx2 followed by ECx1 | Experimental | Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements. |
|
| UPA-ECx1 Normal BMI/weight | Other | Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UPA-ECx1 | Drug | Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Delay in Follicular Rupture Beyond 5 Days | Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI >/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or >50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero. | 1 menstrual cycle, assessed up to 38 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration of Ulipristal Acetate | Maximum serum concentration (Cmax) of UPA in participants with BMI >/=30 kg/m2 with 30 mg UPA, with BMI >/= 30 kg/m2 with 60 mg UPA, and normal BMI participants with 30mg UPA | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALISON EDELMAN, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU | Portland | Oregon | 97239 | United States |
PI acknowledges willingness to share data and materials with other investigators through established means. Data will be shared with collaborators as soon as available; with other scientists before publication if the work to be done is different from our purposes; with local colleagues at seminars and talks including our yearly university wide research-in-progress seminar; and with the scientific community at large by posters and presentations at local, regional, national, and international scientific meetings. Data will be presented via publication to the widest audience possible.
Transfer of resources is subject to the acceptance of a Materials Transfer Agreement as required by policy at OHSU.
OHSU complies with NIH policy on Sharing Research Data and on Sharing Model Organisms.
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| ID | Title | Description |
|---|---|---|
| FG000 | UPA-ECx1 Followed by ECx2 | Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements. UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC |
| FG001 | UPA-ECx2 Followed by ECx1 | Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements. UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC |
| FG002 | UPA-ECx1 Normal BMI/Weight | Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group. UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Primary outcome is analyzed by cycle and dose but demographics were analyzed by group allocation
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| ID | Title | Description |
|---|---|---|
| BG000 | UPA-ECx1 Followed by ECx2 | Ulipristal acetate 30mg orally x 1 dose, washout cycle and then in the next menstrual cycle, 60mg x 1 dose. Timing of dosage depends on follicle measurements. UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC |
| 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 Participants With Delay in Follicular Rupture Beyond 5 Days | Follicular rupture (yes/no) beyond 5 days from EC dosing by ultrasound in participants with a BMI >/=30 kg/m2. The comparison is between menstrual cycles where 30 versus 60 mg of UPA was taken. Follicular rupture is defined as the disappearance of or >50% reduction in size of the leading follicle. The day of EC dosing is defined as day zero. | The total analyzed number is the menstrual cycle of the participant with a BMI >/=30kg/m2 when dosed with ECx1 or ECx2 who experienced a delay in follicular rupture beyond 5 days after dosing EC. | Posted | Count of Participants | Participants | 1 menstrual cycle, assessed up to 38 days |
|
Over approximately 3 months
AE/SAE are consistent with clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECx1 BMI>/=30kg/m2 | Participants with a BMI >/=30kg/m2 in the cycle dosed with 30 mg UPA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. A Edelman | Oregon Health & Science University | 503-418-2585 | edelmana@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2016 | Jan 12, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2016 | Nov 29, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
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|
| UPA-ECx2 | Drug | Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC |
|
|
| Lost to Follow-up |
|
| BG001 | UPA-ECx2 Followed by ECx1 | Ulipristal acetate 60mg orally x 1 dose, washout cycle, and then in next menstrual cycle 30mg orally x 1 dose. Timing of dosage depends on follicle measurements. UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC UPA-ECx2: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC |
| BG002 | UPA-ECx1 Normal BMI/Weight | Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group. UPA-ECx1: Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants were able to indicate more than one Race/Ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 |
| ECx2 BMI >/=30 |
Participants with a BMI >/=30kg/m2 in the cycle dosed with 60 mg UPA |
| OG002 | ECx1 BMI <25kg/m2 | Control group. Participants with a BMI <25kg/m2 in the cycle dosed with 30 mg UPA. No planned statistical comparison analysis with the BMI >/=30 kg/m2 groups |
|
|
| Secondary | Maximum Serum Concentration of Ulipristal Acetate | Maximum serum concentration (Cmax) of UPA in participants with BMI >/=30 kg/m2 with 30 mg UPA, with BMI >/= 30 kg/m2 with 60 mg UPA, and normal BMI participants with 30mg UPA | This was a voluntary aspect of the protocol so data were only collected on a subset of the sample. | Posted | Mean | Standard Deviation | ng/mL | 24 hours |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | ECx2 BMI >/=30kg/m2 | Participants with a BMI >/=30kg/m2 in the cycle dosed with 60 mg UPA | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | ECx1 BMI <25kg/m2 | Control group. Participants with a BMI <25kg/m2 in the cycle dosed with 30 mg UPA | 0 | 12 | 0 | 12 | 0 | 12 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |