Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229996
Status:
COMPLETED
Last Update Posted:
2014-01-24
First Post:
2005-09-28
Brief Title:
Medical Treatment of Endometriosis-Associated Pelvic Pain
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Oral Contraceptives Versus Depot-Leuprolide Taken After Surgery for Endometriosis-Associated Pelvic Pain
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolidenorethindrone 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 leuprolidenorethindrone 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 groupsOne 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 months supply of oral medication capsules containing norethindrone acetate or a generic oral contraceptive with 30ug ethinyl estradiol and 015mg levonorgestrel
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 groupsOne 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 months supply of oral medication capsules containing norethindrone acetate or a generic oral contraceptive with 30ug ethinyl estradiol and 015mg levonorgestrel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None