Bariatric Surgery CandidatePhase 4NCT01941134
Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery
A Phase 4 study testing ethinyl estradiol-levonorgestrel in people with Bariatric Surgery Candidate and Contraception, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will attempt to determine whether having gastric bypass surgery changes the way that the gut absorbs hormones from birth control pills. It is believed that, because gastric bypass surgery causes malabsorption of nutrients and some medications, the levels of birth control hormones after the surgery will be… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate, Contraception
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 6 Dec 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Planning to undergo gastric bypass surgery at our institution
- willing to take 2 monthly cycles of the oral contraceptive: one cycle before and one after surgery
- use of Depo-provera within 6 months of enrollment
- Use of implantable or intrauterine contraception
- able to attend multiple study visits
Who cannot join
- Any contraindication to combined hormonal contraceptive use
- Surgical complications precluding further participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones
This study will attempt to determine whether having gastric bypass surgery changes the way that the gut absorbs hormones from birth control pills. It is believed that, because gastric bypass surgery causes malabsorption of nutrients and some medications, the levels of birth control hormones after the surgery will be lower than in women before they have the surgery. The investigators will ask several women to take a pack of birth control pills before having bypass surgery, and then another pack several months after surgery. The investigators will measure hormone levels in the blood. The investigators will also measure outcomes that may tell us how well the birth control pills are working, such as ultrasounds of the uterus and ovaries, and examination of the cervix.
- Conditions
- Bariatric Surgery Candidate, Contraception
- Being tested
- ethinyl estradiol-levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethinyl estradiol-levonorgestrelDrug
Also called EE-LNG oral contraceptive
Women will be asked to take a daily ethinyl estradiol-levonorgestrel combined oral contraceptive (COC) for 21 days, beginning 2-3 months pre-operatively, so as to stop at least 30 days before planned surgery date. Then, approximately 3-4 months after surgery, they will again be asked to take a daily pill for 21 days. During these pill cycles, we will collect serum samples and perform ultrasound and cervical mucus assessments on a twice-weekly basis, culminating in an inpatient stay of up to 48 hours in order to obtain more frequent sampling at the end of the pill pack.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass COC | Experimental | This is a before-and-after comparison. Women will enroll prior to planned gastric bypass surgery and complete one cycle of oral contraceptive use and evaluation. There will then be no more study procedures/interventions until 3-4 months after surgery. At that time, women will complete the second cycle of OC use and evaluation. Study participation is then complete.
Intervention: Ethinyl estradiol-levonorgestrel(EE 20mcg/LNG 150mcg) Receives: Drug: ethinyl estradiol-levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)
Measured: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Secondary outcomes (4)
Endometrial thickness on transvaginal ultrasound
Measured: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Serum levels of FSH, LH, E and P
Serum levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), estradiol (E) and progesterone (P)
Measured: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Cervical mucus score
We will assess cervical mucus favorability according to standard criteria.
Measured: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Presence of ovarian follicles on transvaginal ultrasound
We will assess for and measure ovarian follicles with maximum diameter 10mm or greater
Measured: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startApr 2013
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
Why it stopped: Recruitment trouble
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Anne Burke, MD MPH, Principal investigator, Johns Hopkins UniversityKimberly Steele, MD, Principal investigator, Johns Hopkins UniversityRoxanne M Jamshidi, MD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941134
- Sponsor's protocol ID
- NA_00009641
- Other IDs
- SFPRF-013-LG
- Status last verified
- Mar 2018
- First submitted
- 12 Jun 2013
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones
- ClinicalTrials.gov ID
- NCT01941134
- Acronym / sponsor ID
- NA_00009641
- Conditions
- Bariatric Surgery Candidate, Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment trouble
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Apr 2013 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 13 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.
This study will attempt to determine whether having gastric bypass surgery changes the way that the gut absorbs hormones from birth control pills. It is believed that, because gastric bypass surgery causes malabsorption of nutrients and some medications, the levels of birth control hormones after the surgery will be lower than in women before they have the surgery. The investigators will ask several women to take a pack of birth control pills before having bypass surgery, and then another pack several months after surgery. The investigators will measure hormone levels in the blood. The investigators will also measure outcomes that may tell us how well the birth control pills are working, such as ultrasounds of the uterus and ovaries, and examination of the cervix.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass COC | Experimental | Drug: ethinyl estradiol-levonorgestrelThis is a before-and-after comparison. Women will enroll prior to planned gastric bypass surgery and complete one cycle of oral contraceptive use and evaluation. There will then be no more study procedures/interventions until 3-4 months after surgery. At that time, women will complete the second cycle of OC use and evaluation. Study participation is then complete. Intervention: Ethinyl estradiol-levonorgestrel(EE 20mcg/LNG 150mcg) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Planning to undergo gastric bypass surgery at our institution
- willing to take 2 monthly cycles of the oral contraceptive: one cycle before and one after surgery
- use of Depo-provera within 6 months of enrollment
- Use of implantable or intrauterine contraception
- able to attend multiple study visits
Key exclusion criteria (2 listed)
- Any contraindication to combined hormonal contraceptive use
- Surgical complications precluding further participation
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: EE-LNG oral contraceptiveWomen will be asked to take a daily ethinyl estradiol-levonorgestrel combined oral contraceptive (COC) for 21 days, beginning 2-3 months pre-operatively, so as to stop at least 30 days before planned surgery date. Then, approximately 3-4 months after surgery, they will again be asked to take a daily pill for 21 days. During these pill cycles, we will collect serum samples and perform ultrasound and cervical mucus assessments on a twice-weekly basis, culminating in an inpatient stay of up to 48 hours in order to obtain more frequent sampling at the end of the pill pack. | Drug | Gastric bypass COC |
Primary outcome
Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)
Time frame: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
4 secondary outcomes
Endometrial thickness on transvaginal ultrasound
Time frame: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Serum levels of FSH, LH, E and P
Time frame: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Cervical mucus score
Time frame: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Presence of ovarian follicles on transvaginal ultrasound
Time frame: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
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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.
Anne Burke, MD MPH principal investigator
Johns Hopkins University
Kimberly Steele, MD principal investigator
Johns Hopkins University
Roxanne M Jamshidi, MD MPH principal investigator
Johns Hopkins 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 Bariatric Surgery Candidate and Contraception, run by Johns Hopkins 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 5 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 Mar 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC) (time frame: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 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 21 Mar 2018.