EndometriosisPhase 3NCT00229996
Medical Treatment of Endometriosis-Associated Pelvic Pain
A Phase 3 study testing Oral Contraceptive and Depot-Leuprolide/Norethindrone in people with Endometriosis and Pelvic Pain, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chronic pelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Pelvic Pain
- What is being tested?
- Oral Contraceptive and Depot-Leuprolide/Norethindrone
- Type of treatment
- Pill or oral medicine
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to not given
- Phase
- Phase 3
- 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 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age greater than 18 and pre-menopausal.
- Pelvic pain of at least 3 months duration.
- Diagnosis of endometriosis by laparoscopy or laparotomy within three years of entry. The diagnosis of endometriosis will require either histology consistent with endometriosis or operative records indicating visual evidence of lesions consistent with endometriosis.
- Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale of 5 or more for three or more months).
- Willingness to comply with visit schedule and protocol.
Who cannot join
- Use of oral contraceptives within one month of the surgery.
- Dose of Lupron within three months if given monthly or within five months if given 3-month injection.
- Any disorder that represents a contraindication to the use of oral contraceptives (e.g. insulin-dependent diabetes mellitus, history of thrombophlebitis, hypertension, history of cardiovascular disease, smoker at 35 or more years of age) or GnRH analogs (e.g., history of osteopenia).
- History of hysterectomy and bilateral salpingoophorectomy.
- Positive pregnancy test at first postoperative (i.e, intake visit).
- Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02215
About this study
Official title: Oral Contraceptives Versus Depot-Leuprolide Taken After Surgery for Endometriosis-Associated Pelvic Pain
The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a 12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse than leuprolide/norethindrone, and that treatment with oral contraceptives is more cost-effective.
Read the detailed description
- Background-Laparoscopic surgical treatment for endometriosis is typically associated with a decrease of pain on a short-term basis, but 50% of patients have pain 12 months after surgery. Often this leads to having repeat surgery to treat the endometriosis. Instead of having repeat surgery, some physicians use medications to prevent the pain and endometriosis from returning.
- The purpose of this study is to compare continuous oral contraceptives to depot-leuprolide for control of endometriosis-associated pelvic pain after surgical treatment of endometriosis. We will also be looking at the potential cost savings of using oral contraceptives compared to depot-leuprolide, as depot-leuprolide is an expensive medication.
- If the patient meets criteria, including confirmation of diagnosis of endometriosis, she will then undergo an intake visit consisting of obtaining informed consent and completion of several baseline questionnaires. This intake visit is estimated to last 1-2 hours. After informed consent has been obtained, the subject will be randomized to one of the two treatment groups:One tablet of oral contraceptives (birth control pills) everyday and an injection of saline (a sterile salt solution with no medication effect) every 12 weeks for 48 weeks or One tablet of norethindrone everyday and an injection of depot-leuprolide every 12 weeks for 48 weeks.
- The patient will be seen one month after the first injection (Visit 1) and then at 12 (Visit 2), 24 (Visit 3), 36 (Visit 4) and 48 (Visit 5) weeks. Blood pressure and weight will be recorded and a urine pregnancy test will be obtained. The Study Coordinator will review with the patient any concerns she might have and record any adverse events. Assessments of pain and quality of life will be made at weeks 4, 12, 24, 36 and 48 after the intake visit. An injection (leuprolide acetate or saline plus inert powder) will be given by an unblinded nurse at the intake visit, and at weeks 12, 24, and 36. In addition, at the end of each medication visit, the patient will be given a three month's supply of oral medication (capsules containing norethindrone acetate or a generic oral contraceptive with 30ug ethinyl estradiol and 0.15mg levonorgestrel).
- Conditions
- Endometriosis, Pelvic Pain
- Being tested
- Oral Contraceptive, Depot-Leuprolide/Norethindrone
- Keywords
- endometriosis, pelvic pain, treatment
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ContraceptiveDrug
Depot-Leuprolide/NorethindroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- David S Guzick, M.D., Ph.D, Principal investigator, University of RochesterMark Hornstein, MD, Principal investigator, Brigham and Women's HospitalFred M Howard, MD, Principal investigator, University of RochesterSara Sukalich, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229996
- Sponsor's protocol ID
- R01HD044870
- Status last verified
- Jan 2014
- First submitted
- 28 Sep 2005
- Last updated
- 24 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Contraceptives Versus Depot-Leuprolide Taken After Surgery for Endometriosis-Associated Pelvic Pain
- ClinicalTrials.gov ID
- NCT00229996
- Acronym / sponsor ID
- R01HD044870
- Conditions
- Endometriosis, Pelvic Pain
- Keywords
- endometriosis, pelvic pain, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 2004
- First posted
- 30 Sep 2005 (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 Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a 12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse than leuprolide/norethindrone, and that treatment with oral contraceptives is more cost-effective.
Detailed description
- Background-Laparoscopic surgical treatment for endometriosis is typically associated with a decrease of pain on a short-term basis, but 50% of patients have pain 12 months after surgery. Often this leads to having repeat surgery to treat the endometriosis. Instead of having repeat surgery, some physicians use medications to prevent the pain and endometriosis from returning.
- The purpose of this study is to compare continuous oral contraceptives to depot-leuprolide for control of endometriosis-associated pelvic pain after surgical treatment of endometriosis. We will also be looking at the potential cost savings of using oral contraceptives compared to depot-leuprolide, as depot-leuprolide is an expensive medication.
- If the patient meets criteria, including confirmation of diagnosis of endometriosis, she will then undergo an intake visit consisting of obtaining informed consent and completion of several baseline questionnaires. This intake visit is estimated to last 1-2 hours. After informed consent has been obtained, the subject will be randomized to one of the two treatment groups:One tablet of oral contraceptives (birth control pills) everyday and an injection of saline (a sterile salt solution with no medication effect) every 12 weeks for 48 weeks or One tablet of norethindrone everyday and an injection of depot-leuprolide every 12 weeks for 48 weeks.
- The patient will be seen one month after the first injection (Visit 1) and then at 12 (Visit 2), 24 (Visit 3), 36 (Visit 4) and 48 (Visit 5) weeks. Blood pressure and weight will be recorded and a urine pregnancy test will be obtained. The Study Coordinator will review with the patient any concerns she might have and record any adverse events. Assessments of pain and quality of life will be made at weeks 4, 12, 24, 36 and 48 after the intake visit. An injection (leuprolide acetate or saline plus inert powder) will be given by an unblinded nurse at the intake visit, and at weeks 12, 24, and 36. In addition, at the end of each medication visit, the patient will be given a three month's supply of oral medication (capsules containing norethindrone acetate or a generic oral contraceptive with 30ug ethinyl estradiol and 0.15mg levonorgestrel).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age greater than 18 and pre-menopausal.
- Pelvic pain of at least 3 months duration.
- Diagnosis of endometriosis by laparoscopy or laparotomy within three years of entry. The diagnosis of endometriosis will require either histology consistent with endometriosis or operative records indicating visual evidence of lesions consistent with endometriosis.
- Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale of 5 or more for three or more months).
- Willingness to comply with visit schedule and protocol.
Key exclusion criteria (6 listed)
- Use of oral contraceptives within one month of the surgery.
- Dose of Lupron within three months if given monthly or within five months if given 3-month injection.
- Any disorder that represents a contraindication to the use of oral contraceptives (e.g. insulin-dependent diabetes mellitus, history of thrombophlebitis, hypertension, history of cardiovascular disease, smoker at 35 or more years of age) or GnRH analogs (e.g., history of osteopenia).
- History of hysterectomy and bilateral salpingoophorectomy.
- Positive pregnancy test at first postoperative (i.e, intake visit).
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 |
|---|---|---|
| Oral Contraceptive | Drug | – |
| Depot-Leuprolide/Norethindrone | Drug | – |
Primary outcome
pain
quality of life
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 24 Jan 2014.
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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.
David S Guzick, M.D., Ph.D principal investigator
University of Rochester
Mark Hornstein, MD principal investigator
Brigham and Women's Hospital
Fred M Howard, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Contraceptive and Depot-Leuprolide/Norethindrone in people with Endometriosis and Pelvic Pain, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 6 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 24 Jan 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
pain. The study lists 2 primary outcomes in all. 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 24 Jan 2014.