Have you or your loved ones been diagnosed with endometriosis-related pain?
You may be eligible to participate in a endometriosis-related pain clinical trial.
Have you or your loved ones been diagnosed with endometriosis-related pain? You may be eligible to participate in a endometriosis-related pain clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Endometriosis-related Pain Clinical Trial
Have you or your loved ones been diagnosed with endometriosis-related pain?
You may be eligible to participate in a endometriosis-related pain clinical trial.
Have you or your loved ones been diagnosed with endometriosis-related pain? You may be eligible to participate in a endometriosis-related pain clinical trial.
Completed
Female
18 Years +
To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain
Details for the study
Brief Title
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing Efficacy, Safety, Dose-response of Quinagolide Vaginal Rings Administered Sequentially for 4 Menstrual Cycles in Women With Moderate-Severe Endometriosis-related Pain
Brief Summary
To evaluate the efficacy of three doses of quinagolide administered as an extended-release <br /> vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related <br /> pain
Treatments and/or Procedures
Placebo
Matching placebo
Quinagolide 1080 µg
Vaginal ring containing quinagolide 1080 µg for daily releases
Quinagolide 720 µg
Vaginal ring containing quinagolide 720 µg for daily releases
Quinagolide 360 µg
Vaginal ring containing quinagolide 360 µg for daily releases
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Changes in the mean daily Numerical Rating Scale (NRS) scores compared to baseline for the worst endometriosis related pain.
Assessed daily by participants in an e-Diary. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Secondary
Proportion of participants with markedly abnormal changes in urinalysis parameters
Assessed by urine samples collection
Secondary
Proportion of participants with markedly abnormal changes in circulating levels of clinical haematology parameters
Assessed by blood samples collection
Secondary
Proportion of participants with markedly abnormal changes in circulating levels of clinical chemistry parameters
Assessed by blood samples collection
Secondary
Changes in urinalysis parameters (protein, glucose, bilirubin, pH, nitrite, ketone, urobilinogen, blood, leukocytes, and specific gravity)
Assessed by urine sample collection (dip-stick test)
Secondary
Changes in circulating levels of clinical haematology parameters
Assessed by blood samples collection
Secondary
Serum levels of mid-luteal estradiol, prolactin, thyroid-stimulating hormone (TSH) and insulin-like growth factor-1 (IGF-1)
Assessed by blood samples collection
Secondary
Changes in circulating levels of clinical chemistry parameters
Assessed by blood samples collection
Secondary
Frequency and intensity of adverse events
Assessed by an Adverse Events Log completed by the Investigator
Secondary
Proportion of subjects identified with potential impulse control disorders
Assessed by the questionnaire for impulsive-compulsive disorders completed by subjects
Secondary
Proportion of subjects with abnormal clinically significant echocardiography findings indicating valvular heart disease
Assessed by echocardiography
Secondary
Number of subjects with no changes, non-significant changes and significant changes in ECG
Assessed by 12-lead ECG
Secondary
Changes in bone turnover markers, determined by bone resorption marker serum C-terminal crosslinking telopeptide of type 1 collagen (s-CTx) and bone formation marker serum procollagen type I N propeptide (s-PINP)
Assessed by blood samples collection
Secondary
Frequency and intensity of ring acceptability parameters
Assessed by a questionnaire completed by participants, addressing ring insertion/removal, any feeling of the ring while the ring is in the body, any feeling of the ring during sexual intercourse if applicable and any experience of ring falling out or breaking.
Secondary
Proportion of subjects with serum mid-luteal progesterone levels ≥25 nmol/L (7.9 ng/ml)
Assessed by blood samples collection
Secondary
Changes in vaginal bleeding pattern.
Assessed participants by subjects in an e-Diary
Secondary
Plasma concentration of quinagolide and metabolites
Assessed by blood samples collection
Secondary
Changes in the mean daily Numerical Rating Scale (NRS) scores for the worst endometriosis-related pain on days with menstrual bleeding and for the worst endometriosis-related pain on days with no menstrual bleeding
Assessed daily by participants in an e-Diary. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Secondary
Changes in the mean daily Numerical Rating Scale (NRS) scores for the worst endometriosis-related pain.
Assessed daily by participants in an e-Diary. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Secondary
Changes in the mean daily Numerical Rating Scale (NRS) scores for the worst dysmenorrhea.
Assessed daily by participants in an e-Diary. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Secondary
Changes in the mean daily Numerical Rating Scale (NRS) scores for the worst non-menstrual pelvic pain.
Assessed daily by participants in an e-Diary. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Secondary
Changes in the mean daily Numerical Rating Scale (NRS) scores for the worst dyspareunia on days with sexual intercourse.
Assessed daily by participants in an e-Diary. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Secondary
Frequency of avoiding sexual intercourse due to expected pain
Assessed daily by participants in an e-Diary
Secondary
Serum levels of mid-luteal phase progesterone
Assessed by blood samples collection
Secondary
Changes in the mean daily scores for the worst impact of endometriosis-related pain on the subject's ability to function.
Assessed daily by participants in an e-Diary.
Secondary
Percentage of days with mild and/or strong rescue analgesics used
Assessed daily by participants in an e-Diary
Secondary
Total and average doses of mild and/or strong rescue analgesics used
Assessed daily by participants in an e-Diary
Secondary
Responder rate
Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact
Secondary
Changes in the mean individual and total symptom and sign severity scores
Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe.
Secondary
Changes in the Endometriosis Health Profile-30 (EHP-30) scores
Assessed by the EHP-30 quality-of-life questionnaire completed by subjects. Score ranges from 0-100 with lower score denoting improvement.
Secondary
Changes in Patient Global Impression of Severity (PGIS) scores
Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a subject's rating of their current conditions from "good" to "bad".
Secondary
Patient Global Impression of Change (PGIC) scores
Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad".
Secondary
Changes in the mean weekly scores of the Endometriosis Health Profile-30 (EHP-30) pain impact domain.
Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.
Study Criteria
Inclusion Criteria: - Pre-menopausal females aged ≥18 years at time of signing informed consent(s). - Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening. - Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound. - Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit. - Having moderate to severe endometriosis-related pain. - Willing to use a non-hormonal barrier method (i.e. condom) for contraception from randomization to the end-of-trial. This is not required if adequate contraception is achieved by vasectomy of the sexual partner or surgical sterilisation of the subject. - Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices from randomization to the end of treatment. - Willing to change usual analgesics to rescue analgesics as permitted by protocol for endometriosis-related pain from the start of run-in to the end-of-trial. Exclusion Criteria: - Use of depot medroxyprogesterone acetate (MPA) within 10 months of the start of run-in. - Use of gonadotropin releasing hormone (GnRH) agonists (3 months depot) or dopamine agonists within 6 months of the start of run-in. - Use of GnRH agonists (1 month depot) or intrauterine device within 3 months of the start of run-in. - Use of GnRH antagonist, combined oral contraceptive pill or progestin-only pill within 1 month of the start of run-in. - Undiagnosed abnormal vaginal bleeding. - History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary. - Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers. - Any significant abnormal findings of heart examinations before randomization.