Trial · NCT06611501
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months | once at each of the three visits (at baseline, 3 months, 6 months) | The BPI Interference Scale is a 7-item composite pain measurement. This self-report measure assesses the extent to which pain interferes with various components of physical and emotional functioning and sleep. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied. |
| Primary | Change in pain severity measured by Visual Analog Scale (VAS) over 6 months | once at each of the three visits (at baseline, 3 months, 6 months) | VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity. |
| Primary | Change in emotional functioning assessed by Beck Depression Inventory-II (BDI) over 6 months | once at each of the three visits (at baseline, 3 months, 6 months) | The BDI is a 21-item self-report instrument that provides a rapid assessment of depressive symptoms. BDI has been used in many studies of chronic pain, including chronic pelvic pain and endometriosis. Total scores on the BDI range from 0 to 63. The BDI takes about 5-10 minutes to complete. Scores below 13 should be considered to reflect "minimal or no" depression, with score ranges of 14 to 19, 20 to 28, and 29 to 63 reflect "mild to moderate," "moderate to severe," and "severe" depression, respectively. |
| Primary | Change in ratings of overall improvement assessed by the Patient Global Impression of Change scale (PGIC) | once at each of the three visits (at baseline, 3 months, 6 months) | The PGIC is a seven-point single-item scale with options ranging from 'very much worse' to 'very much improved'. There has been widespread use of the PGIC in recent endometriosis clinical trials, as it readily interprets a person's evaluation of the importance of their improvement or worsening. |
| Secondary | Change in quality of life, measured via Endometriosis Health Profile-30 (EHP-30) | once at each of the three visits (at baseline, 3 months, 6 months) | The EHP-30 is a reliable instrument and recommended by the American Society for Reproductive Medicine and the European Society for Human Reproduction and Embryology. The questionnaire includes 30 questions in five subcategories, with each category addressing specific problem areas of pain, control and powerlessness, emotional wellbeing, social support, and self-image. |
| Secondary | Changes in sexual satisfaction for participants who are sexually active measured by the New Sexual Satisfaction Scale | once at each of the three visits (at baseline, 3 months, 6 months) | The NSSS is a 20-item measure assessing sexual sensations, sexual presence/awareness, sexual exchange, emotional connection/closeness, and sexual activity. The full scale takes 5 minutes to complete. |
| Secondary | Complete health and medication history assessed by the World Endometriosis Research Foundation (WERF) questionnaire | once at each of the three visits (at baseline, 3 months, 6 months) | Study participants will complete an expanded version of the WERF questionnaire for a complete health and medication history |
| Secondary | Changes in serum angiogenic/inflammatory markers | once at each of the three visits (at baseline, 3 months, 6 months) | Serum samples will also be obtained for measures of inflammation, to test the hypothesis that endometriosis-relevant inflammatory markers will decrease over time in patients treated with metformin compared to those receiving placebo. These markers will include IL-6, IL-8, and VEGF based on the results of prior studies in which metformin appeared to reduce these levels in humans with endometriosis and from endometriotic implants in rats. C-reactive protein (CRP) will also be assessed; CRP has been shown to be upregulated, especially when examined with a high sensitivity assay making it possible to detect subclinical inflammation in women with endometriosis. |
| Other | Changes in school and/or work attendance | once at each of the three visits (at baseline, 3 months, 6 months) | School and/or work attendance will be assessed at each visit. |
| Other | Change in pregnancy status | once at each of the three visits (at baseline, 3 months, 6 months) | Urine pregnancy test throughout the study as current pregnancy is an exclusion criteria |
| Other | Changes in serum lactate levels | baseline, three and six months if needed | Serum lactate will be measured at baseline and then possibly at three and six months, if needed. |
| Other | Changes in pain | daily for 6 months | Subjects will keep a daily symptom diary to track pain for 6 months. |
| Other | Incidence of vaginal bleeding over six months | daily for 6 months | Measurement of the incidence of vaginal bleeding using a daily symptom diary to document the presence/absence of vaginal bleeding |
| Other | Usage of any pain medications (both prescription and over the counter) | daily for 6 months | Usage of any pain medications (both prescription and over the counter) tracked in a daily symptom diary for 6 months |
| Other | Changes in height | once at each of the three visits (at baseline, 3 months, 6 months) | Height, in cm, will be obtained at each study visit (at baseline, 3 months, and 6 months). |
| Other | Changes in weight | once at each of the three visits (at baseline, 3 months, 6 months) | Study subjects will have their weight obtained at each study visit given the potential impact on weight by metformin. |
| Other | Changes in serum insulin c-peptide level | at baseline and 6 months | Serum insulin c-peptide levels will be collected at baseline and again at 6-months given metformin impact on lowering c-peptide levels. |
| Other | Changes in hemoglobin and mean corpuscular volume | at baseline and 6 months | A Complete Blood Count (CBC) will be collected at baseline and again at 6-months due to the potential adverse effect of megaloblastic anemia by metformin, which would be detected by the hemoglobin and mean corpuscular volume. |
| Other | Changes in vitamin B12 levels | at baseline and 6 months | Serum vitamin B12 levels will be obtained at baseline and at 6 months due to the possible adverse effect of vitamin b12 deficiency by metformin |
| Other | Changes in lipid levels | at baseline and 6 months | A lipid panel will be collected at baseline and again at 6-months due to the potential lipid-lowering activity of metformin. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT06611501/registered