Phase 3 Endometriosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing and able to sign a written consent form to take part in the study
• You are a woman of childbearing age (premenopausal) between 18 and 45 years old
• You have been diagnosed with endometriosis (stage I, II, or III) through surgery (laparoscopy or laparotomy) at least 2 weeks ago but no more than 60 months (5 years) ago
• Your periods happen naturally (without hormonal treatment) and come every 24 to 38 days, and this has been the case for the past 2 cycles and during the screening period
• You do not currently need surgery for your endometriosis
• You have had pelvic pain related to endometriosis that scores 3.5 or higher on a 10-point pain scale, both in the 2 cycles before screening and during the screening cycle
• You have other symptoms of endometriosis, such as painful periods, pain during sex, pain when going to the toilet, or findings shown on an ultrasound or MRI scan
• You agree to use highly effective contraception throughout the study and for 2 months after it ends
• You have a negative pregnancy test
• You filled in a daily symptom diary on at least 75% of days during the screening period

Who may not be able to join:

• You have a known reason why you cannot take the study drug Indinol Forto (indolcarbinol)
• You have a known reason why you cannot take the study drug Visanne (dienogest)
• You have had unexplained or abnormal vaginal or urinary bleeding in the past 6 months
• You have long-term pelvic pain caused by something other than endometriosis, such as fibroids or another gynaecological or urological condition
• You have long-term pain in other parts of the body not caused by endometriosis (for example, fibromyalgia, ongoing back pain, or frequent headaches) that requires ongoing pain treatment
• You have endometrioid cysts that are 3 cm or larger
• You have had your uterus removed (hysterectomy), both ovaries removed (bilateral oophorectomy), or have premature ovarian failure (note: having had your tubes tied or removed is allowed)
• You have another significant gynaecological condition found during screening, such as ovarian cysts larger than 3 cm lasting more than 4 months, or an active sexually transmitted infection (confirm with trial site — rescreening may be possible after treatment)
• Your endometriosis pain has not improved at all with previous treatments such as the contraceptive pill, hormone therapies, or similar medications (note: partial response or stopping due to side effects may still be acceptable — confirm with trial site)
• You have had cancer in the past 5 years, except for certain treated skin cancers or cervical cancer in situ
• You have severe kidney disease (confirm with trial site)
• Your blood pressure is too high during the screening period (above 160/90 mmHg)
• Your blood test results during screening show significant problems with liver function, low red blood cells (anaemia), or low white blood cells or platelets
• You have an overactive or underactive thyroid gland based on blood test results
• You are pregnant, have been pregnant in the last 3 months, or are currently breastfeeding
• You have a history of alcohol or drug misuse
• You have taken part in another clinical trial within the past 90 days
• You have any other medical condition, need for surgery, or required treatment that the study doctor believes could make participation unsafe or affect the study results

Important: Always verify eligibility with the trial site directly before applying.