ContraceptionNCT01944306
Obesity and Oral Contraceptive Failure
An observational study of Contraception and Fetal Growth Retardation, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. 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, Fetal Growth Retardation, Infant, Small for Gestational Age
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2015
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive-aged, ovulatory women seeking to initiate contraception with combined oral contraceptives will be recruited from the female population of the Portland, OR area. Subjects must have access to their birth weight record. Enrollment will be confined to women who have not used a hormonal contraceptive method for 30 days or more prior to enrollment.
Who may be able to join
- age 18 to 35.
- single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to dosing with oral contraceptives.
Who cannot join
- absolute/relative contraindications to ethinyl estradiol and levonorgestrel.
- impaired liver function.
- history of deep venous thrombosis.
- hypertension (> 140/90).
- diabetes with vascular changes.
- migraines with aura or neurological changes.
Show all 16Show fewer
- history of myocardial infarction, pulmonary embolus, stroke or breast cancer.
- anemia (hematocrit < 36%).
- actively seeking or involved in a weight loss program (must be weight stable)
- pregnancy, breastfeeding, or seeking pregnancy.
- diagnosis of Polycystic Ovarian Syndrome.
- recent (4 week) use of hormonal contraceptives (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.
- smokers.
- uncontrolled thyroid dysfunction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Prenatal Growth Programs Oral Contraceptive Metabolism and Effectiveness
Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese women, defined by their own birth weight, are at higher risk of contraceptive failure. Further studies are necessary to investigate whether birth weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for the identification of women prone to contraceptive failure. Such an understanding is critical to finding a contraceptive strategy with better efficacy for these women.
The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in obese women with low birth weight and compare to obese women with normal birth weight. The main hypothesis for this proposal is that an adverse in utero environment programs the expression and function of enzymes and transporters that underlie pharmacokinetics of oral contraceptives, and leads to contraceptive failure.
Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8 lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for 1 month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol, progesterone) will be monitored.
- Keywords
- Pharmacokinetics, Pharmacology, Clinical, Drug Efficacy, Drug Failure, Contraceptive Agents
- Medical subject headings
- Fetal Growth Retardation, 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 |
|---|---|---|
| Low birth-weight, obese | Not described | |
| Low birth-weight, normal body weight | Not described | |
| Normal birth-weight, obese | Not described | |
| Normal birth-weight, normal body weight | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure pharmacokinetic parameters of oral contraceptives including drug clearance.
Serum concentration-time data for each subject will be analyzed using a non-compartmental model assumption. Serum concentrations below the lower limit of quantitation (LLOQ) at the beginning and end of the profile will be set to zero. Serum concentration-time profiles will be summarized using descriptive statistics and graphical display. Student t-tests will be used to test whether the average values of each of the pharmacokinetic parameters, including free concentrations, differ between the four groups of women.
Measured: on day 21 of oral contraceptive use
Secondary outcomes (1)
Measure levels of gonadotropins and ovarian hormones
To compare gonadotopin levels, average leutinizing hormone and follicle stimulating hormone levels measured for days 21-25 will be calculated. In addition, the follicle stimulating hormone/leutinizing hormone ratio will be calculated at each time point. The average levels of these measures will then be compared between the four groups of women using a student's t-test.
Measured: Days 21-25 of oral contraceptive use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Due to lack of funds, the study has been terminated upon recruiting less than desired number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 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
- Sponsor
- Investigators
- Ganesh Cherala, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944306
- Sponsor's protocol ID
- IRB00009569
- Other IDs
- 2K12HD043488-11
- Status last verified
- Dec 2019
- First submitted
- 10 Sep 2013
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Edelman AB, Carlson NE, Cherala G, Munar MY, Stouffer RL, Cameron JL, Stanczyk FZ, Jensen JT. Impact of obesity on oral contraceptive pharmacokinetics and hypothalamic-pituitary-ovarian activity. Contraception. 2009 Aug;80(2):119-27. doi: 10.1016/j.contraception.2009.04.011. Epub 2009 Jun 4.
PubMed 19631786Cherala G, Thornburg K, Edelman A. Birthweight and cytochrome P4503A4/5 activity in obese women. Br J Clin Pharmacol. 2013 Jan;75(1):275-6. doi: 10.1111/j.1365-2125.2012.04309.x. No abstract available.
PubMed 22534035Edelman AB, Cherala G, Munar MY, Dubois B, McInnis M, Stanczyk FZ, Jensen JT. Prolonged monitoring of ethinyl estradiol and levonorgestrel levels confirms an altered pharmacokinetic profile in obese oral contraceptives users. Contraception. 2013 Feb;87(2):220-6. doi: 10.1016/j.contraception.2012.10.008. Epub 2012 Nov 12.
PubMed 23153898Edelman A, Cherala G, Lim JY, Jensen JT. Contraceptive failures in overweight and obese combined hormonal contraceptive users. Obstet Gynecol. 2013 Jul;122(1):158-159. doi: 10.1097/AOG.0b013e3182995811. No abstract available.
PubMed 23787930
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Growth Programs Oral Contraceptive Metabolism and Effectiveness
- ClinicalTrials.gov ID
- NCT01944306
- Acronym / sponsor ID
- IRB00009569
- Keywords
- Pharmacokinetics, Pharmacology, Clinical, Drug Efficacy, Drug Failure, Contraceptive Agents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to lack of funds, the study has been terminated upon recruiting less than desired number of subjects
- Enrolment
- 26 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
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 17 Sep 2013 (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.
Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese women, defined by their own birth weight, are at higher risk of contraceptive failure. Further studies are necessary to investigate whether birth weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for the identification of women prone to contraceptive failure. Such an understanding is critical to finding a contraceptive strategy with better efficacy for these women.
The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in obese women with low birth weight and compare to obese women with normal birth weight. The main hypothesis for this proposal is that an adverse in utero environment programs the expression and function of enzymes and transporters that underlie pharmacokinetics of oral contraceptives, and leads to contraceptive failure.
Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8 lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for 1 month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol, progesterone) will be monitored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low birth-weight, obese | – | – |
| Low birth-weight, normal body weight | – | – |
| Normal birth-weight, obese | – | – |
| Normal birth-weight, normal body weight | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive-aged, ovulatory women seeking to initiate contraception with combined oral contraceptives will be recruited from the female population of the Portland, OR area. Subjects must have access to their birth weight record. Enrollment will be confined to women who have not used a hormonal contraceptive method for 30 days or more prior to enrollment.
Key inclusion criteria (2 listed)
- age 18 to 35.
- single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to dosing with oral contraceptives.
Key exclusion criteria (16 listed)
- absolute/relative contraindications to ethinyl estradiol and levonorgestrel.
- impaired liver function.
- history of deep venous thrombosis.
- hypertension (> 140/90).
- diabetes with vascular changes.
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
Measure pharmacokinetic parameters of oral contraceptives including drug clearance.
Time frame: on day 21 of oral contraceptive use
Serum concentration-time data for each subject will be analyzed using a non-compartmental model assumption. Serum concentrations below the lower limit of quantitation (LLOQ) at the beginning and end of the profile will be set to zero. Serum concentration-time profiles will be summarized using descriptive statistics and graphical display. Student t-tests will be used to test whether the average values of each of the pharmacokinetic parameters, including free concentrations, differ between the four groups of women.
1 secondary outcome
Measure levels of gonadotropins and ovarian hormones
Time frame: Days 21-25 of oral contraceptive use
Results and safety
The study was stopped early (reason given: Due to lack of funds, the study has been terminated upon recruiting less than desired number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Background: PubMed 19631786Edelman AB, Carlson NE, Cherala G, Munar MY, Stouffer RL, Cameron JL, Stanczyk FZ, Jensen JT. Impact of obesity on oral contraceptive pharmacokinetics and hypothalamic-pituitary-ovarian activity. Contraception. 2009 Aug;80(2):119-27. doi: 10.1016/j.contraception.2009.04.011. Epub 2009 Jun 4.
- Background: PubMed 22534035Cherala G, Thornburg K, Edelman A. Birthweight and cytochrome P4503A4/5 activity in obese women. Br J Clin Pharmacol. 2013 Jan;75(1):275-6. doi: 10.1111/j.1365-2125.2012.04309.x. No abstract available.
- Background: PubMed 23153898Edelman AB, Cherala G, Munar MY, Dubois B, McInnis M, Stanczyk FZ, Jensen JT. Prolonged monitoring of ethinyl estradiol and levonorgestrel levels confirms an altered pharmacokinetic profile in obese oral contraceptives users. Contraception. 2013 Feb;87(2):220-6. doi: 10.1016/j.contraception.2012.10.008. Epub 2012 Nov 12.
- Background: PubMed 23787930Edelman A, Cherala G, Lim JY, Jensen JT. Contraceptive failures in overweight and obese combined hormonal contraceptive users. Obstet Gynecol. 2013 Jul;122(1):158-159. doi: 10.1097/AOG.0b013e3182995811. No abstract available.
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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.
Ganesh Cherala, PhD 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?
An observational study of Contraception and Fetal Growth Retardation, 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 2 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Dec 2019. 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 was stopped early (reason given: Due to lack of funds, the study has been terminated upon recruiting less than desired number of subjects). Results are not available in the source record.
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?
Measure pharmacokinetic parameters of oral contraceptives including drug clearance. (time frame: on day 21 of oral contraceptive use). 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 NCT01944306, which also lists 4 linked publications.
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 13 Dec 2019.