Body WeightPhase 4NCT01170390
Oral Contraceptives and Body Mass Index
A Phase 4 study testing All participants (Aviane), Portia and Aviane in people with Body Weight and Contraceptive Usage, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness 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
- Body Weight, Contraceptive Usage
- What is being tested?
- All participants (Aviane), Portia and Aviane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2011
- 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
- Age 18-35
- BMI > 30kg/m2
- Proof of a normal breast and pelvic exam within last 9 months
- Self reported normal menstrual periods (24-35 days)
- Good general health
- In the investigator's opinion, are subject's veins suitable the repeat blood draws dictated by study protocol
- Single progesterone level during screening visit ≥ 3ng/mL
- Hematocrit ≥ 36%
Who cannot join
- Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
- Smoker (must smoke 0 cigarettes)
- Actively seeking/involved in a weight loss program
- Currently pregnant/seeking pregnancy in the next 6 months
- Currently breast-feeding
- Past or current diagnosis of polycystic ovarian disease
- Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants: 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6 months)
- Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St. John's Wort)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Improving Contraceptive Effectiveness in Obese Women
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
Read the detailed description
This study is being conducted to understand how effective oral hormonal birth control (the pill) is for women with high body mass index ("BMI" - the ratio of your height and weight BMI"). Previous studies of birth control traditionally do not include women above a certain BMI number, so safety and efficacy is not clearly understood in this population, yet the pill is still widely used in women with high BMI.
Reproductive-aged, ovulatory women of obese (BMI >30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.
- Conditions
- Body Weight, Contraceptive Usage
- Being tested
- All participants (Aviane), Portia, Aviane
- Keywords
- Obesity, Body weight, Oral contraception, Efficacy
- Medical subject headings
- Body Weight, Contraception Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All participants (Aviane)Drug
Also called Levonorgestrel and Ethinyl Estradiol
20 mcg EE/0.1 mg LNG cyclically
PortiaDrug
Also called Levonorgestrel and Ethinyl Estradiol
30 mcg EE/0.15 mg LNG cyclically
AvianeDrug
Also called Levonorgestrel and Ethinyl Estradiol
20 mcg EE/0.1 mg LNG continuously dosed
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). Receives: Drug: All participants (Aviane) |
| Aviane and Portia | Active comparator | A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles Receives: Drug: Portia |
| Aviane & Aviane | Active comparator | A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval) Receives: Drug: Aviane |
What is being measured
The primary outcome is the main question the study is designed to answer.
LNG Steady State at Baseline and Then Post-randomization
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).
Measured: baseline (2 months) and post-randomization (4 months)
Secondary outcomes (4)
LNG AUC
Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.
Measured: post-randomization (4 months)
LNG AUC
Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.
Measured: baseline (2 months)
EE Steady State Baseline
Steady state levels of ethinyl estradiol (EE) at baseline (2 months)
Measured: Baseline (2 months)
EE Steady State After Randomization
Steady state levels of ethinyl estradiol (EE) post- randomization
Measured: Post-randomiziation 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionDec 2011
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 Body WeightStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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
- NCT01170390
- Sponsor's protocol ID
- OHSU FAMPLAN 5382
- Other IDs
- R01HD061582
- Status last verified
- Nov 2015
- First submitted
- 27 Oct 2009
- Last updated
- 31 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Edelman AB, Cherala G, Munar MY, McInnis M, Stanczyk FZ, Jensen JT. Correcting oral contraceptive pharmacokinetic alterations due to obesity: a randomized controlled trial. Contraception. 2014 Nov;90(5):550-6. doi: 10.1016/j.contraception.2014.06.033. Epub 2014 Jun 27.
PubMed 25070547
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Contraceptive Effectiveness in Obese Women
- ClinicalTrials.gov ID
- NCT01170390
- Acronym / sponsor ID
- OHSU FAMPLAN 5382
- Conditions
- Body Weight, Contraceptive Usage
- Keywords
- Obesity, Body weight, Oral contraception, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Posted 26 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
Detailed description
This study is being conducted to understand how effective oral hormonal birth control (the pill) is for women with high body mass index ("BMI" - the ratio of your height and weight BMI"). Previous studies of birth control traditionally do not include women above a certain BMI number, so safety and efficacy is not clearly understood in this population, yet the pill is still widely used in women with high BMI.
Reproductive-aged, ovulatory women of obese (BMI >30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Drug: All participants (Aviane)A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). |
| Aviane and Portia | Active comparator | Drug: PortiaA low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles |
| Aviane & Aviane | Active comparator | Drug: AvianeA very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-35
- BMI > 30kg/m2
- Proof of a normal breast and pelvic exam within last 9 months
- Self reported normal menstrual periods (24-35 days)
- Good general health
Key exclusion criteria (8 listed)
- Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
- Smoker (must smoke 0 cigarettes)
- Actively seeking/involved in a weight loss program
- Currently pregnant/seeking pregnancy in the next 6 months
- Currently breast-feeding
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 |
|---|---|---|
| All participants (Aviane)Also: Levonorgestrel and Ethinyl Estradiol20 mcg EE/0.1 mg LNG cyclically | Drug | All participants |
| PortiaAlso: Levonorgestrel and Ethinyl Estradiol30 mcg EE/0.15 mg LNG cyclically | Drug | Aviane and Portia |
| AvianeAlso: Levonorgestrel and Ethinyl Estradiol20 mcg EE/0.1 mg LNG continuously dosed | Drug | Aviane & Aviane |
Primary outcome
LNG Steady State at Baseline and Then Post-randomization
Time frame: baseline (2 months) and post-randomization (4 months)
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).
4 secondary outcomes
LNG AUC
Time frame: post-randomization (4 months)
LNG AUC
Time frame: baseline (2 months)
EE Steady State Baseline
Time frame: Baseline (2 months)
EE Steady State After Randomization
Time frame: Post-randomiziation 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25070547Edelman AB, Cherala G, Munar MY, McInnis M, Stanczyk FZ, Jensen JT. Correcting oral contraceptive pharmacokinetic alterations due to obesity: a randomized controlled trial. Contraception. 2014 Nov;90(5):550-6. doi: 10.1016/j.contraception.2014.06.033. Epub 2014 Jun 27.
- (OHSU Women's Health Research Unit)Link provided by the sponsor.
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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 All participants (Aviane), Portia and Aviane in people with Body Weight and Contraceptive Usage, 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 8 inclusion and 8 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 31 Dec 2015. 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 26 Nov 2015). 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?
LNG Steady State at Baseline and Then Post-randomization (time frame: baseline (2 months) and post-randomization (4 months)). 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 NCT01170390, 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 31 Dec 2015.