Skip to main content
OpenTrials
Completed

NCT Number: NCT03692403

Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometriosis-related Pain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Marchand Institute for Minimally Invasive Surgery, Mesa, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
  • 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.
  • Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.

Exclusion criteria

  • 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.
  • History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in)
  • History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization.
  • History of orthostatic hypotension or recurrent syncope.

Treatment and study plan

Quinagolide 360 µg

Drug

Vaginal ring containing quinagolide 360 µg for daily releases

Other names: FE 999051

Quinagolide 720 µg

Drug

Vaginal ring containing quinagolide 720 µg for daily releases

Other names: FE 999051

Quinagolide 1080 µg

Drug

Vaginal ring containing quinagolide 1080 µg for daily releases

Other names: FE 999051

Placebo

Drug

Matching placebo

Primary outcomes

  1. Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes from baseline to cycle 4.

Secondary outcomes

  1. 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

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4

  2. Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles

  3. Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles

  4. Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles

  5. Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles.

  6. Frequency of Avoiding Sexual Intercourse Due to Expected Pain

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: "Yes" (I did not have intercourse this day, because I expected pain) or "No" (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants.

    In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.

  7. Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles.

  8. Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    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.

    Changes over 4 menstrual cycles.

  9. Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: "Yes" (I had a vaginal bleeding that was menstrual bleeding) or "No" (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants.

    In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.

  10. Changes in Vaginal Bleeding Pattern.

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants.

    In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.

  11. Percentage of Days With Mild and/or Strong Rescue Analgesics Used

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary

  12. Total and Average Doses of Mild and/or Strong Rescue Analgesics Used

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed daily by participants in an e-Diary

  13. Responder Rate

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    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

  14. Changes in the Mean Individual and Total Symptom and Sign Severity Scores

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by the Biberoglu and Behrman (B&B) scale which is a 4-point scale with 0=none and 3=severe.

    The scores are the mean individual scores.

    The B&B scale consists of two parts. The first part of the B&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15.

    The values are the change from baseline to cycle 4.

  15. Changes in the Endometriosis Health Profile-30 (EHP-30) Scores

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement.

  16. Changes in Patient Global Impression of Severity (PGIS) Scores

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from "good" to "bad".

    It ranges from 0 (none) to 5 (very severe).

  17. Patient Global Impression of Change (PGIC) Scores

    Time frame: At cycle 4 (around 4 months, each cycle is approximately 28 days)

    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".

  18. Plasma Concentration of Quinagolide and Metabolites

    Time frame: Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days)

    Assessed by blood samples collection

  19. Serum Levels of Mid-luteal Phase Progesterone

    Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)

    Assessed by blood samples collection

  20. Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)

    Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)

    Assessed by blood samples collection

  21. Serum Levels of Estradiol

    Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)

    Assessed by blood samples collection

  22. Serum Levels of Prolactin

    Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)

    Assessed by blood samples collection

  23. Serum Levels of Thyrotropin (TSH)

    Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)

    Assessed by blood samples collection

  24. Serum Levels of Insulin-like Growth Factor-1 (IGF-1)

    Time frame: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)

    Assessed by blood samples collection

  25. Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by blood samples collection. Changes from baseline to cycle 4

  26. Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by blood samples collection. Changes from baseline to cycle 4

  27. Changes in ECG Parameters Including PR Interval at Cycle 4

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by 12-lead ECG

  28. Changes in ECG Parameters Including QRS Duration at Cycle 4

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by 12-lead ECG

  29. Changes in ECG Parameters Including QT Interval at Cycle 4

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by 12-lead ECG

  30. Changes in ECG Parameters Including QTcF Interval at Cycle 4

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by 12-lead ECG

  31. Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by echocardiography.

    Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well.

    Measured at cycle 4.

  32. Proportion of Subjects Identified With Potential Impulse Control Disorders

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by the questionnaire for impulsive-compulsive disorders completed by participants.

    Measured at cycle 4.

  33. Frequency and Intensity of Adverse Events

    Time frame: From signing informed consent through study completion, around 8 months

    Assessed by an Adverse Events Log completed by the Investigator

  34. Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  35. Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  36. Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  37. Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  38. Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  39. Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  40. Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  41. Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  42. Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  43. Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  44. Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  45. Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  46. Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  47. Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  48. Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  49. Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  50. Changes in Circulating Levels of Clinical Chemistry Parameters: Protein

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  51. Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  52. Changes in Circulating Levels of Clinical Chemistry Parameters: Urate

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  53. Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  54. Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  55. Changes in Circulating Levels of Clinical Haematology Parameters: Basophils

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  56. Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  57. Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  58. Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  59. Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  60. Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  61. Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  62. Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  63. Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  64. Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  65. Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  66. Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  67. Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  68. Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  69. Changes in Circulating Levels of Clinical Haematology Parameters: Platelets

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  70. Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  71. Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  72. Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result.

  73. Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  74. Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters

    Time frame: At baseline and at menstrual cycle 4 (around 4 months)

    Assessed by blood samples collection

  75. Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters

    Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by urine samples collection

  76. Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by a questionnaire completed by participants, addressing ring insertion

  77. Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by a questionnaire completed by participants, addressing ring removal.

  78. Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring

    Time frame: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

    Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing the Efficacy, Safety and Dose-response of Quinagolide Extended-release Vaginal Rings Administered Sequentially for 4 Menstrual Cycles in Women With Moderate to Severe Endometriosis-related Pain

Acronym: RAQUEL

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 2, 2018
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.