ContraceptionNCT00724438
Pharmacokinetics of Implanon in Obese Women
An observational study of Contraception and Obesity, run by University of Chicago at 1 site in United States.
Trial summary
Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Obesity
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2011
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from resident and faculty practices at the University of Chicago outpatient facilities and from the University of Chicago clinical trails database of past study participants.
Who may be able to join
- premenopausal with a uterus and at least one ovary
- willing and able to sign the informed consent
- willing to comply with the study protocol and visit schedule
- have a body mass index of less than 25, or greater than or equal to 30
- weight stable
Who cannot join
- known or suspected pregnancy
- delivery (vaginal or cesarean) within 4 months of device insertion
- abortion (first or second trimester) within 4 months of device insertion
- contraindications to Implanon use
- hemophilia
- undiagnosed abnormal genital bleeding
Show all 19Show fewer
- hypersensitivity or allergy to any components of Implanon
- personal or family history of thrombosis or thromboembolic disorders
- hepatic tumors or active liver disease
- known or suspected carcinoma of the breast or history of breast cancer
- more that one cardiovascular risk factor such as hypertension or diabetes
- known history of PCOS, diabetes, or glucose abnormality
- present use or use within 2 months of device insertion of a CYP3A4 inducer
- breastfeeding women
- use of an investigational drug within 2 months of device insertion
- use of injectable contraception within 6 months of device insertion
- planning a pregnancy in the next 12 months
- known HIV infection
- smoking over the age of 35
Trial locations and contacts
1 site in 1 country.
About this study
Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.
- Conditions
- Contraception, Obesity
- Keywords
- Contraception, Implanon, Obesity, Blood spots, Implant, Pharmacokinetics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Obese women: women with a body mass index (BMI) >30 | |
| 2 | Normal weight women: women with a BMI <25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.
Measured: 6 months
Secondary outcomes (5)
To describe ease of insertion and palpation of Implanon among obese women
Measured: 6 months
To describe bleeding patterns among obese users of Implanon
Measured: 6 months
To describe the acceptability of Implanon among obese women
Measured: 6 months
To describe the discontinuation rates, reason for discontinuation, and ease of removal in obese women who discontinue the device before or at the end of the 6 month study period
Measured: 6 months
To determine whether etonogestrel levels can be obtained from finger-stick blood spots
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
- Investigators
- Melissa Gilliam, MD, MPH, Principal investigator, University of ChicagoSara J Mornar, DO, Study director, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724438
- Sponsor's protocol ID
- 15956A
- Status last verified
- Sep 2013
- First submitted
- 25 Jul 2008
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Implanon in Obese Women
- ClinicalTrials.gov ID
- NCT00724438
- Acronym / sponsor ID
- 15956A
- Conditions
- Contraception, Obesity
- Keywords
- Contraception, Implanon, Obesity, Blood spots, Implant, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Jul 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Jul 2008 (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.
Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Obese women: women with a body mass index (BMI) >30 |
| 2 | – | –Normal weight women: women with a BMI <25 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from resident and faculty practices at the University of Chicago outpatient facilities and from the University of Chicago clinical trails database of past study participants.
Key inclusion criteria (5 listed)
- premenopausal with a uterus and at least one ovary
- willing and able to sign the informed consent
- willing to comply with the study protocol and visit schedule
- have a body mass index of less than 25, or greater than or equal to 30
- weight stable
Key exclusion criteria (19 listed)
- known or suspected pregnancy
- delivery (vaginal or cesarean) within 4 months of device insertion
- abortion (first or second trimester) within 4 months of device insertion
- contraindications to Implanon use
- hemophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.
Time frame: 6 months
5 secondary outcomes
To describe ease of insertion and palpation of Implanon among obese women
Time frame: 6 months
To describe bleeding patterns among obese users of Implanon
Time frame: 6 months
To describe the acceptability of Implanon among obese women
Time frame: 6 months
To describe the discontinuation rates, reason for discontinuation, and ease of removal in obese women who discontinue the device before or at the end of the 6 month study period
Time frame: 6 months
To determine whether etonogestrel levels can be obtained from finger-stick blood spots
Time frame: 6 months
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 5 Sep 2013.
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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.
Melissa Gilliam, MD, MPH principal investigator
University of Chicago
Sara J Mornar, DO study director
University of Chicago
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 Contraception and Obesity, run by University of Chicago 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 5 inclusion and 19 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 5 Sep 2013. 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?
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women. (time frame: 6 months). 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 5 Sep 2013.