ObesityPhase 4UPA-ObesityNCT02859337
Effectiveness of Orally Dosed Emergency Contraception in Obese Women - UPA
A Phase 4 study testing UPA-ECx1 and UPA-ECx2 in people with Obesity and Contraception, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Contraception
- What is being tested?
- UPA-ECx1 and UPA-ECx2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 15 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy women
- Aged 18-35 years old
- Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
- Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI <25kg/m2 and a weight of less than 80kg.
Who cannot join
- Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
- Impaired liver or renal function
- Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
- Recent (within last 8 weeks) use of hormonal contraception
- Current use of drugs that interfere with metabolism of sex steroids
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
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.
Read the detailed description
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.
- Conditions
- Obesity, Contraception
- Being tested
- UPA-ECx1, UPA-ECx2
- Keywords
- obesity, body weight, BMI, emergency contraception, levonorgestrel, ulipristal acetate
- Medical subject headings
- Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPA-ECx1Drug
Also called Ella, Ella-One
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
UPA-ECx2Drug
Also called ella, ella-one
Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: UPA-ECx1; Drug: UPA-ECx2 |
| 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. Receives: Drug: UPA-ECx1; Drug: UPA-ECx2 |
| 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. Receives: Drug: UPA-ECx1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 menstrual cycle, assessed up to 38 days
Secondary outcomes (1)
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start30 May 2017
- Primary completion13 Jan 2022
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Alison Edelman, Oregon Health and Science University
- Investigators
- ALISON EDELMAN, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859337
- Sponsor's protocol ID
- OHSU IRB 016291
- Acronym
- UPA-Obesity
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2016
- Last updated
- 6 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Effectiveness of Orally Dosed Emergency Contraceptives in Obese Women - PK and PD of 30mg and 60mg UPA
- ClinicalTrials.gov ID
- NCT02859337
- Acronym / sponsor ID
- UPA-Obesity / OHSU IRB 016291
- Conditions
- Obesity, Contraception
- Keywords
- obesity, body weight, BMI, emergency contraception, levonorgestrel, ulipristal acetate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Posted 6 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UPA-ECx1 followed by ECx2 | Active comparator | Drug: UPA-ECx1, Drug: UPA-ECx2Ulipristal 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 | Drug: UPA-ECx1, Drug: UPA-ECx2Ulipristal 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 | Drug: UPA-ECx1Ulipristal acetate 30mg orally x 1 dose. timing of dosage depends on follicle measurements. This is to obtain a normal BMI control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Generally healthy women
- Aged 18-35 years old
- Regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/mL or greater
- Subjects must have a BMI of >30kg/m2 and weight at least 80kg or more OR a BMI <25kg/m2 and a weight of less than 80kg.
Key exclusion criteria (6 listed)
- Metabolic disorders including uncontrolled thyroid dysfunction and Polycystic Ovarian Syndrome
- Impaired liver or renal function
- Actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy
- Recent (within last 8 weeks) use of hormonal contraception
- Current use of drugs that interfere with metabolism of sex steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPA-ECx1Also: Ella, Ella-OneEvaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC | Drug | UPA-ECx1 Normal BMI/weight, UPA-ECx1 followed by ECx2, UPA-ECx2 followed by ECx1 |
| UPA-ECx2Also: ella, ella-oneEvaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC | Drug | UPA-ECx1 followed by ECx2, UPA-ECx2 followed by ECx1 |
Primary outcome
Number of Participants With Delay in Follicular Rupture Beyond 5 Days
Time frame: 1 menstrual cycle, assessed up to 38 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 secondary outcome
Maximum Serum Concentration of Ulipristal Acetate
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALISON EDELMAN, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing UPA-ECx1 and UPA-ECx2 in people with Obesity and Contraception, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Delay in Follicular Rupture Beyond 5 Days (time frame: 1 menstrual cycle, assessed up to 38 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.