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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD061582 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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 |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All participants (Aviane) | Drug | 20 mcg EE/0.1 mg LNG cyclically |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline (2 months) and post-randomization (4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25070547 | Derived | 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. |
| Label | URL |
|---|---|
| (OHSU Women's Health Research Unit) | View source |
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A prospective cohort study was conducted at the Oregon Health & Science University (OHSU) in Portland, OR, from March 2006 to September 2007. Recruitment included print ads in local newspapers, flyers posted in the Center for Women's Health & other OHSU clinics and public places, and electronic postings to web sites such as Craig's List.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months |
| FG001 | Study Arm #1 (Aviane and Aviane) | A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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) |
| FG002 | Study Arm #2 (Aviane and Portia) | A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Oral Contraceptives |
| |||||||||||||
| Randomized Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aviane and Aviane | A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | One subject discontinued prior to the completion of the baseline studies in the Aviane/Aviane arm | Posted | Mean | Standard Deviation | ng/mL | baseline (2 months) and post-randomization (4 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aviane and Aviane | A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Edelman | Oregon Health & Science University | 503.418.2585 | edelmana@ohsu.edu |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| D003268 | Contraception Behavior |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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| Portia | Drug | 30 mcg EE/0.15 mg LNG cyclically |
|
|
| Aviane | Drug | 20 mcg EE/0.1 mg LNG continuously dosed |
|
|
| 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. | baseline (2 months) |
| EE Steady State Baseline | Steady state levels of ethinyl estradiol (EE) at baseline (2 months) | Baseline (2 months) |
| EE Steady State After Randomization | Steady state levels of ethinyl estradiol (EE) post- randomization | Post-randomiziation 4 months |
| NOT COMPLETED |
|
| Aviane and Portia |
A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Aviane and Portia |
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). 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 |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hr*ng/mL | post-randomization (4 months) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hr*ng/mL | baseline (2 months) |
|
|
|
| Secondary | EE Steady State Baseline | Steady state levels of ethinyl estradiol (EE) at baseline (2 months) | One subject discontinued prior to the completion of the baseline cycle in the Aviane/Aviane arm | Posted | Mean | Standard Deviation | ng/mL | Baseline (2 months) |
|
|
|
| Secondary | EE Steady State After Randomization | Steady state levels of ethinyl estradiol (EE) post- randomization | Posted | Mean | Standard Deviation | ng/mL | Post-randomiziation 4 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Aviane and Portia | A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). 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 | 0 | 15 | 0 | 15 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |