ObesityNCT02104609
Effects of Obesity on Pharmacokinetics of the Levonorgestrel Emergency Contraceptive Pill
An observational study of Obesity, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of obesity on the pharmacokinetics of the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of ovulation Primary hypothesis: 1) Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution… 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
- What is being tested?
- Levonorgestrel 1.5mg by mouth once
- Type of treatment
- Pill or oral medicine
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to May 2016
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Non-smoking women between ages 18-35 years with regular menstrual cycles (24-35 days) will be enrolled, to include 10 normal weight (BMI = 18.5-24.9 kg/m2) women, 10 obese (BMI = 30-39.9 kg/m2) and 10 extremely obese (BMI ≥ 40 kg/m2) women
Who may be able to join
- Women between ages 18-35 years
- Regular menstrual cycles (24-35 days) for the past 2 months
- Ovulatory at defined by midluteal progesterone level >3 ng/mL (Day 18-25)
- Belongs to one of the following categories: normal weight (BMI = 18.5-24.9 kg/m2), obese (BMI = 30-39.9 kg/m2) or extremely obese (BMI ≥ 40 kg/m2)
- Participant has no intention of or desire to conceive (e.g., active attempt to become pregnant or in vitro fertilization) for the duration of the study
- Participant agrees to consistently use an effective method of nonhormonal contraception throughout the duration of study, which could include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, non-hormonal intra-uterine devise (IUD), or sterilization.
- Able to give informed consent
Who cannot join
- • Known renal or liver disease
- Known pituitary disorder
- Known adrenal disorder
- Known thyroid disorder
- Use of medication known to alter the cytochrome P450 system
- Use of depot-medroxyprogesterone acetate in the previous 6 months or any other hormonal contraceptive in the previous 3 months
Show all 11Show fewer
- Currently breastfeeding
- Pregnant
- Pregnancy in the prior month
- Known allergy to medication
- Other specific contraindications to LNG EC
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
The purpose of this study is to determine the effects of obesity on the pharmacokinetics of the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of ovulation
Primary hypothesis:
- Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution of LNG.
Secondary hypothesis:
- Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women affect the primary mechanism of action, which is inhibition of ovulation.
- Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free LNG.
- Conditions
- Obesity
- Being tested
- Levonorgestrel 1.5mg by mouth once
- Keywords
- Obesity, Emergency contraception, Levonorgestrel emergency contraception
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel 1.5mg by mouth onceDrug
Also called Plan B One Step, Next Choice One Dose
Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
| Study group | Role | What they receive |
|---|---|---|
| Normal weight women | Levonorgestrel 1.5mg by mouth once Receives: Drug: Levonorgestrel 1.5mg by mouth once | |
| Obese women | Levonorgestrel 1.5mg by mouth once Receives: Drug: Levonorgestrel 1.5mg by mouth once | |
| Extremely obese women | Levonorgestrel 1.5mg by mouth once Receives: Drug: Levonorgestrel 1.5mg by mouth once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Secondary outcomes (3)
Time to maximum concentration (Tmax)
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Minimum concentration (Cmin)
Measured: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Area under the concentration time-curve (AUC)
Measured: Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Melissa Natavio, University of Southern California
- Investigators
- M Natavio, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104609
- Sponsor's protocol ID
- HS-12-00602
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of the Levonorgestrel-only Emergency Contraception Regimen in Normal-weight, Obese and Extremely Obese Users: a Pilot Study
- ClinicalTrials.gov ID
- NCT02104609
- Acronym / sponsor ID
- HS-12-00602
- Conditions
- Obesity
- Keywords
- Obesity, Emergency contraception, Levonorgestrel emergency contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of obesity on the pharmacokinetics of the levonorgestrel (LNG) only emergency contraceptive (EC) regimen and on markers of ovulation
Primary hypothesis:
- Obese users of LNG-EC have a pharmacokinetic profile that is consistent with a larger volume of distribution of LNG.
Secondary hypothesis:
- Alterations in these pharmacokinetic parameters of the LNG-EC regimen in obese women affect the primary mechanism of action, which is inhibition of ovulation.
- Obesity may affect other factors that alter levels of LNG, such as sex-hormone binding globulin (SHBG) and albumin, which bind LNG and potentially lowers the amount of free LNG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight women | – | Drug: Levonorgestrel 1.5mg by mouth onceLevonorgestrel 1.5mg by mouth once |
| Obese women | – | Drug: Levonorgestrel 1.5mg by mouth onceLevonorgestrel 1.5mg by mouth once |
| Extremely obese women | – | Drug: Levonorgestrel 1.5mg by mouth onceLevonorgestrel 1.5mg by mouth once |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Non-smoking women between ages 18-35 years with regular menstrual cycles (24-35 days) will be enrolled, to include 10 normal weight (BMI = 18.5-24.9 kg/m2) women, 10 obese (BMI = 30-39.9 kg/m2) and 10 extremely obese (BMI ≥ 40 kg/m2) women
Key inclusion criteria (7 listed)
- Women between ages 18-35 years
Key exclusion criteria (11 listed)
- • Known renal or liver disease
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 |
|---|---|---|
| Levonorgestrel 1.5mg by mouth onceAlso: Plan B One Step, Next Choice One DoseLevonorgestrel 1.5mg by mouth given on menstrual cycle day 8 | Drug | Extremely obese women, Normal weight women, Obese women |
Primary outcome
Maximum concentration (Cmax)
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
3 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Minimum concentration (Cmin)
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours
Area under the concentration time-curve (AUC)
Time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 6, 24, 48, 72 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
M Natavio principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Southern California 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 7 inclusion and 11 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 18 Apr 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum concentration (Cmax) (time frame: Time 0, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours). 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 18 Apr 2019.