ContraceptionPhase 4NCT00662454
Oral Contraceptive Efficacy and Body Weight
A Phase 4 study testing ethinyl estradiol / levonorgestrel 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 the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. 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?
- ethinyl estradiol / levonorgestrel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2006
- Phase
- Phase 4
- 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
Who may be able to join
- age 18 to 35
- single baseline hematocrit ≥ 36%
- single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.
Who cannot join
- any absolute contraindications to ethinyl estradiol and levonorgestrel
- smoking
- actively seeking or involved in a weight loss program (must be weight stable)
- pregnancy, breastfeeding, or seeking pregnancy
- diagnosis of Polycystic Ovarian Syndrome
- recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
- DepoProvera use within six months
- current use of drugs that interfere with metabolism of sex steroids.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?
The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.
Read the detailed description
The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.
- Conditions
- Contraception, Body Weight
- Being tested
- ethinyl estradiol / levonorgestrel
- Keywords
- contraceptive, efficacy, body weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethinyl estradiol / levonorgestrelDrug
Also called Alesse
Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
ethinyl estradiol / levonorgestrelDrug
Also called Alesse
Take one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | 10 normal weight women (BMI < 25 kg/m2) Receives: Drug: ethinyl estradiol / levonorgestrel |
| II | Active comparator | 10 obese women (BMI >30 kg/m2) Receives: Drug: ethinyl estradiol / levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
Measured: Approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionMay 2006
- Study completionMay 2006
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Oregon Clinical and Translational Research Institute
- 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
- NCT00662454
- Sponsor's protocol ID
- OHSU FAMPLAN 0411
- Other IDs
- NIH R03 HD053611 01
- Status last verified
- Sep 2020
- First submitted
- 16 Apr 2008
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?
- ClinicalTrials.gov ID
- NCT00662454
- Acronym / sponsor ID
- OHSU FAMPLAN 0411
- Conditions
- Contraception, Body Weight
- Keywords
- contraceptive, efficacy, body weight
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Oregon Clinical and Translational Research Institute
- Study start
- Jan 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 21 Apr 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.
The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.
Detailed description
The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: ethinyl estradiol / levonorgestrel10 normal weight women (BMI < 25 kg/m2) |
| II | Active comparator | Drug: ethinyl estradiol / levonorgestrel10 obese women (BMI >30 kg/m2) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18 to 35
- single baseline hematocrit ≥ 36%
- single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.
Key exclusion criteria (8 listed)
- any absolute contraindications to ethinyl estradiol and levonorgestrel
- smoking
- actively seeking or involved in a weight loss program (must be weight stable)
- pregnancy, breastfeeding, or seeking pregnancy
- diagnosis of Polycystic Ovarian Syndrome
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 |
|---|---|---|
| ethinyl estradiol / levonorgestrelAlso: AlesseTake one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration. | Drug | I |
| ethinyl estradiol / levonorgestrelAlso: AlesseTake one tablet daily of 20 mcg ethinyl estradiol/100 mcg levonorgestrel for 21 days plus 7 days of placebo tablets, repeat for two months total duration. | Drug | II |
Primary outcome
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
Time frame: Approximately one year
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 16 Sep 2020.
- OHSU Women's Health Research UnitLink 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 ethinyl estradiol / levonorgestrel 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 3 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 16 Sep 2020. 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?
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?
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts (time frame: Approximately one year). 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 16 Sep 2020.