Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611501
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Glycemic Regulation As Endometriosis Adjunct Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Glycemic Regulation As Endometriosis Adjunct Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREAT
Brief Summary:
The goal of this pilot trial is to learn if a novel non-hormonal treatment metformin hydrochloride works to treat pelvic pain in young women with endometriosis The main questions it aims to answer are
Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis
Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis
Researchers will compare metformin to a placebo a look-alike substance that contains no drug to see if metformin works to treat pelvic pain
Participants will
Take drug metformin or a placebo every day for 6 months
Visit the clinic three times once at baseline pre-treatment once at 3 months and once at 6 months
Keep a daily symptom diary to track pain bleeding and usage of any pain medications
Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis
Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis
Researchers will compare metformin to a placebo a look-alike substance that contains no drug to see if metformin works to treat pelvic pain
Participants will
Take drug metformin or a placebo every day for 6 months
Visit the clinic three times once at baseline pre-treatment once at 3 months and once at 6 months
Keep a daily symptom diary to track pain bleeding and usage of any pain medications
Detailed Description:
Endometriosis is a chronic illness defined by the presence of endometrial glands and stroma outside the uterine lining While prevalence estimates vary depending on the population studied endometriosis is thought to affect approximately one in ten reproductive aged women up to 50 of women with infertility and up to 70 of adolescents with chronic pelvic pain Over 10 million women in the United States have endometriosis and incur significantly higher direct and indirect healthcare costs than those without Annual health care costs are estimated at 100 billion in the United States alone While the majority of patients report the onset of endometriosis symptoms during adolescence delays in diagnosis are common and range from 7 to 12 years During these delays women may suffer from debilitating symptoms interfering with school and social activities and commonly experience reduced health-related quality of life and work productivity When left untreated endometriosis can progress significantly in over 50 of patients and result in a higher stage of disease Therefore timely intervention and maintenance of therapy is critical for preventing the progression of disease and patient burden
Therapeutic options for endometriosis include surgical and medical management Because surgery is not curative long-term medical therapy is often advised to prevent recurrence of symptoms and retard the progression of disease Nonsteroidal anti-inflammatory drugs NSAIDs are commonly used for endometriosis-related pain but do not remove or decrease deposits of ectopic endometrium Hormonal therapies are the mainstay of medical therapy as they can inhibit prostaglandin production that contributes to pain and cause decidualization and atrophy of ectopic endometrial tissue Unfortunately hormonal treatments have varied degrees of success and no data support one treatment over another Additionally the treatment choice may be limited to medication side effects availability costs and contraceptive needs Hormonal treatments do not cure endometriosis 11-19 of women may not experience any relief with medical therapy and up to a third of women experience recurrence of pain symptoms after treatment cessation Additionally as endometriosis is predominantly a disease of young reproductive-aged women patients may desire a treatment with a different mechanism of action that does not impact ovarian function and fertility There remains an unmet clinical need among women with endometriosis for effective and well-tolerated medical therapies
Metformin an insulin-sensitizing oral biguanide is approved for the treatment of type 2 diabetes Several published studies using in vitro and animal models have implicated metformin with a regression of endometriotic implants and reduction of inflammatory activity Yet the mechanisms of action of metformin remain to be further elucidated Only one prospective study to date has investigated the use of metformin in humans as monotherapy for endometriosis this study had substantial limitations Further investigation will be improved with participant and provider blinding use of validated pain measures and inclusion of a broader population of patients affected by endometriosis A randomized clinical trial is necessary to investigate the mechanisms and efficacy of metformin as an anti-endometriotic drug
Therapeutic options for endometriosis include surgical and medical management Because surgery is not curative long-term medical therapy is often advised to prevent recurrence of symptoms and retard the progression of disease Nonsteroidal anti-inflammatory drugs NSAIDs are commonly used for endometriosis-related pain but do not remove or decrease deposits of ectopic endometrium Hormonal therapies are the mainstay of medical therapy as they can inhibit prostaglandin production that contributes to pain and cause decidualization and atrophy of ectopic endometrial tissue Unfortunately hormonal treatments have varied degrees of success and no data support one treatment over another Additionally the treatment choice may be limited to medication side effects availability costs and contraceptive needs Hormonal treatments do not cure endometriosis 11-19 of women may not experience any relief with medical therapy and up to a third of women experience recurrence of pain symptoms after treatment cessation Additionally as endometriosis is predominantly a disease of young reproductive-aged women patients may desire a treatment with a different mechanism of action that does not impact ovarian function and fertility There remains an unmet clinical need among women with endometriosis for effective and well-tolerated medical therapies
Metformin an insulin-sensitizing oral biguanide is approved for the treatment of type 2 diabetes Several published studies using in vitro and animal models have implicated metformin with a regression of endometriotic implants and reduction of inflammatory activity Yet the mechanisms of action of metformin remain to be further elucidated Only one prospective study to date has investigated the use of metformin in humans as monotherapy for endometriosis this study had substantial limitations Further investigation will be improved with participant and provider blinding use of validated pain measures and inclusion of a broader population of patients affected by endometriosis A randomized clinical trial is necessary to investigate the mechanisms and efficacy of metformin as an anti-endometriotic drug
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