AzTrials
AzTrials

Endometriosis-related PainPhase 2RAQUELNCT03692403

Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

A Phase 2 study testing Quinagolide 360 µg, Quinagolide 720 µg and Quinagolide 1080 µg in people with Endometriosis-related Pain, run by Ferring Pharmaceuticals at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis-related Pain
What is being tested?
Quinagolide 360 µg, Quinagolide 720 µg and Quinagolide 1080 µg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
43 sitesUnited States
Study dates
26 Dec 2018to 14 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • The Iowa Clinic

    Ankeny, Iowa, 50023

  • Austin Area Ob, Gyn and Fertility

    Austin, Texas, 78758

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Main Line Fertility Center

    Bryn Mawr, Pennsylvania, 19010

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Corpus Christi Women's Clinic

    Corpus Christi, Texas, 78412

  • Omega Research Consultants

    DeBary, Florida, 32713

  • Carolina's Women's Research and Wellness Center

    Durham, North Carolina, 27713

  • UConn Health Lowell P Weicker Jr Clinical Research Center

    Farmington, Connecticut, 06030

  • Rapha Institute For Clinical Research

    Fayetteville, North Carolina, 28314

  • Onyx Clinical Research

    Flint, Michigan, 48532

  • Penn State Health - Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Advances in Health, Inc.

    Houston, Texas, 77030

  • Arkansas Primary Care Clinic

    Little Rock, Arkansas, 72204

  • Advance Clinical Research

    Meridian, Idaho, 83643

  • Marchand Institute for Minimally Invasive Surgery

    Mesa, Arizona, 85209

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001

  • South Florida Research Center

    Miami, Florida, 33135

  • Florida Research Center

    Miami, Florida, 33174

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176

  • Vista Health Research

    Miami, Florida, 33176

  • Yale Fertility Center

    New Haven, Connecticut, 06511

  • Advanced Research Institute

    New Port Richey, Florida, 34653

  • Tidewater Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • OB/GYN Specialists of Richmond

    Richmond, Virginia, 23229

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Valley OB/GYN Clinic, PC

    Saginaw, Michigan, 48602

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Physician Care Clinical Research

    Sarasota, Florida, 34239

  • Omni Fertility Clinical Research LLC

    Shreveport, Louisiana, 71118

  • OB/Gyn Associates

    Silver Spring, Maryland, 20910

  • Southern Illinois University

    Springfield, Illinois, 62794-9664

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Center of Reproductive Medicine LLC

    Webster, Texas, 77598

  • OB•GYN Associates of WNY

    West Seneca, New York, 14224

  • Cypress Medical Research Center

    Wichita, Kansas, 67226

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

  • Unified Women's Clinical Research d/b/a Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official 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

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

Being tested
Quinagolide 360 µg, Quinagolide 720 µg, Quinagolide 1080 µg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quinagolide 360 µgDrug

    Also called FE 999051

    Vaginal ring containing quinagolide 360 µg for daily releases

  • Quinagolide 720 µgDrug

    Also called FE 999051

    Vaginal ring containing quinagolide 720 µg for daily releases

  • Quinagolide 1080 µgDrug

    Also called FE 999051

    Vaginal ring containing quinagolide 1080 µg for daily releases

  • PlaceboDrug

    Matching placebo

Study groups in NCT03692403
Study groupRoleWhat they receive
Quinagolide 360 µgExperimentalVaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Receives: Drug: Quinagolide 360 µg
Quinagolide 720 µgExperimentalVaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Receives: Drug: Quinagolide 720 µg
Quinagolide 1080 µgExperimentalVaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Receives: Drug: Quinagolide 1080 µg
PlaceboPlacebo comparatorVaginal ring containing matching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes from baseline to cycle 4.

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

Secondary outcomes (78)

  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

    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

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

  2. 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 an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles

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

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

    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

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

  4. 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 an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles

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

  5. 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 an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.

    Changes over 4 menstrual cycles.

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

  6. Frequency of Avoiding Sexual Intercourse Due to Expected Pain

    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.

    Measured: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 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.

    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.

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

  8. 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.

    Changes over 4 menstrual cycles.

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

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

    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.

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

  10. Changes in Vaginal Bleeding Pattern.

    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.

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

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

    Assessed daily by participants in an e-Diary

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

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

    Assessed daily by participants in an e-Diary

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

  13. 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

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

  14. 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.

    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.

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

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

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

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

  16. 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 participant's rating of their current conditions from "good" to "bad".

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

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

  17. 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".

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

  18. Plasma Concentration of Quinagolide and Metabolites

    Assessed by blood samples collection

    Measured: 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)

  19. Serum Levels of Mid-luteal Phase Progesterone

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

  21. Serum Levels of Estradiol

    Assessed by blood samples collection

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

  22. Serum Levels of Prolactin

    Assessed by blood samples collection

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

  23. Serum Levels of Thyrotropin (TSH)

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

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

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

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

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

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

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

    Assessed by 12-lead ECG

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

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

    Assessed by 12-lead ECG

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

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

    Assessed by 12-lead ECG

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

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

    Assessed by 12-lead ECG

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

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

    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.

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

  32. Proportion of Subjects Identified With Potential Impulse Control Disorders

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

    Measured at cycle 4.

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

  33. Frequency and Intensity of Adverse Events

    Assessed by an Adverse Events Log completed by the Investigator

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

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

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

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

    Assessed by blood samples collection

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

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

    Assessed by blood samples collection

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

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

    Assessed by urine samples collection

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

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

    Assessed by a questionnaire completed by participants, addressing ring insertion

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start26 Dec 2018
  3. Primary completion14 Feb 2022
  4. Study completion14 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692403
Sponsor's protocol ID
000165
Acronym
RAQUEL
Status last verified
Oct 2022
First submitted
14 Sep 2018
Last updated
18 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quinagolide 360 µg, Quinagolide 720 µg and Quinagolide 1080 µg in people with Endometriosis-related Pain, run by Ferring Pharmaceuticals at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03692403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.

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