ContraceptionPhase 4NCT02408692
Emergency Contraception and Body Weight: Pilot Study
A Phase 4 study testing ECx1 and ECx2 in people with Contraception and Body Weight, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent… 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
- Contraception, Body Weight
- What is being tested?
- ECx1 and ECx2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Aug 2015
- 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
- Subjects are between the ages of 18 and 35
- Subjects are in good general health
- Subjects have regular menstrual cycles (between 21 and 35 days)
- Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).
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 (8 week) 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.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.
Read the detailed description
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.
We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
- Conditions
- Contraception, Body Weight
- Being tested
- ECx1, ECx2
- Keywords
- Emergency contraception, Obese BMI, Normal BMI
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECx1Drug
Also called Next choice, Emergency Contraception
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
ECx2Drug
Also called Next choice, Emergency Contraception
At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
| Study group | Role | What they receive |
|---|---|---|
| Normal BMI ECx1 | Active comparator | 5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG Receives: Drug: ECx1 |
| Obese BMI ECx1 | Active comparator | 5 obese women (BMI >30 kg/m2) taking 1.5mg LNG Receives: Drug: ECx1 |
| Obese BMI ECx2 | Active comparator | 5 obese women (BMI >30 kg/m2) taking 3mg LNG Receives: Drug: ECx2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
Measured: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Secondary outcomes (1)
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel
Measured: Follicular phase of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionAug 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Foundation, Oregon
- 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
- NCT02408692
- Sponsor's protocol ID
- OHSU IRB 11419
- Status last verified
- Sep 2017
- First submitted
- 27 Mar 2015
- Last updated
- 25 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: PI acknowledges willingness to share data and materials with other investigators through established means. Data will be presented via presentation and publication. 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.
Publications
Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.
PubMed 27000996
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Contraception and Body Weight: Pilot Study
- ClinicalTrials.gov ID
- NCT02408692
- Acronym / sponsor ID
- OHSU IRB 11419
- Conditions
- Contraception, Body Weight
- Keywords
- Emergency contraception, Obese BMI, Normal BMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Medical Research Foundation, Oregon
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Posted 2 Jun 2017
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 research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (LNG). This emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. The overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.
Detailed description
To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free LNG serum concentrations.
We enrolled healthy, reproductive-age women with obese and normal BMIs received 1.5 mg LNG orally and then in a subsequent menstrual cycle, the obese group also received 3 mg LNG. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal BMI ECx1 | Active comparator | Drug: ECx15 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG |
| Obese BMI ECx1 | Active comparator | Drug: ECx15 obese women (BMI >30 kg/m2) taking 1.5mg LNG |
| Obese BMI ECx2 | Active comparator | Drug: ECx25 obese women (BMI >30 kg/m2) taking 3mg LNG |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects are between the ages of 18 and 35
- Subjects are in good general health
- Subjects have regular menstrual cycles (between 21 and 35 days)
- Subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (IUD).
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 (8 week) 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 |
|---|---|---|
| ECx1Also: Next choice, Emergency ContraceptionAt the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation. | Drug | Normal BMI ECx1, Obese BMI ECx1 |
| ECx2Also: Next choice, Emergency ContraceptionAt the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours) | Drug | Obese BMI ECx2 |
Primary outcome
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel
Time frame: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5
Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel
1 secondary outcome
Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel
Time frame: Follicular phase of menstrual cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27000996Edelman AB, Cherala G, Blue SW, Erikson DW, Jensen JT. Impact of obesity on the pharmacokinetics of levonorgestrel-based emergency contraception: single and double dosing. Contraception. 2016 Jul;94(1):52-7. doi: 10.1016/j.contraception.2016.03.006. Epub 2016 Mar 18.
- Individual participant dataSharing planned: Yes. PI acknowledges willingness to share data and materials with other investigators through established means. Data will be presented via presentation and publication. 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.
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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 ECx1 and ECx2 in people with Contraception and Body Weight, 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 25 Oct 2017. 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 2 Jun 2017). 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?
Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel (time frame: Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408692, which also lists 1 linked publication.
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 25 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.