Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

NCT03692403 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 000165
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 43

Brief 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

Conditions

Endometriosis-related Pain

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (78)

• 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

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

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

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

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

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

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

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

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

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

Study Arms (4)

Quinagolide 360 µg

EXPERIMENTAL

Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg

Drug: Quinagolide 360 µg

Quinagolide 720 µg

EXPERIMENTAL

Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg

Drug: Quinagolide 720 µg

Quinagolide 1080 µg

EXPERIMENTAL

Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg

Drug: Quinagolide 1080 µg

Placebo

PLACEBO COMPARATOR

Vaginal ring containing matching placebo

Drug: Placebo

Interventions

Quinagolide 360 µg DRUG

Vaginal ring containing quinagolide 360 µg for daily releases

Also known as: FE 999051

Quinagolide 360 µg

Quinagolide 720 µg DRUG

Vaginal ring containing quinagolide 720 µg for daily releases

Also known as: FE 999051

Quinagolide 720 µg

Quinagolide 1080 µg DRUG

Vaginal ring containing quinagolide 1080 µg for daily releases

Also known as: FE 999051

Quinagolide 1080 µg

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (43)

Marchand Institute for Minimally Invasive Surgery

Mesa, Arizona, 85209, United States

Location

Arkansas Primary Care Clinic

Little Rock, Arkansas, 72204, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

UConn Health Lowell P Weicker Jr Clinical Research Center

Farmington, Connecticut, 06030, United States

Location

Yale Fertility Center

New Haven, Connecticut, 06511, United States

Location

Omega Research Consultants

DeBary, Florida, 32713, United States

Location

South Florida Research Center

Miami, Florida, 33135, United States

Location

Florida Research Center

Miami, Florida, 33174, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Advanced Research Institute

New Port Richey, Florida, 34653, United States

Location

Physician Care Clinical Research

Sarasota, Florida, 34239, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Advance Clinical Research

Meridian, Idaho, 83643, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Southern Illinois University

Springfield, Illinois, 62794-9664, United States

Location

The Iowa Clinic

Ankeny, Iowa, 50023, United States

Location

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Omni Fertility Clinical Research LLC

Shreveport, Louisiana, 71118, United States

Location

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

OB/Gyn Associates

Silver Spring, Maryland, 20910, United States

Location

Onyx Clinical Research

Flint, Michigan, 48532, United States

Location

Valley OB/GYN Clinic, PC

Saginaw, Michigan, 48602, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

OB•GYN Associates of WNY

West Seneca, New York, 14224, United States

Location

PMG Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

Carolina's Women's Research and Wellness Center

Durham, North Carolina, 27713, United States

Location

Rapha Institute For Clinical Research

Fayetteville, North Carolina, 28314, United States

Location

Lyndhurst Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

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

Winston-Salem, North Carolina, 27103, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Penn State Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Austin Area Ob, Gyn and Fertility

Austin, Texas, 78758, United States

Location

Corpus Christi Women's Clinic

Corpus Christi, Texas, 78412, United States

Location

Advances in Health, Inc.

Houston, Texas, 77030, United States

Location

Center of Reproductive Medicine LLC

Webster, Texas, 77598, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Tidewater Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

OB/GYN Specialists of Richmond

Richmond, Virginia, 23229, United States

Location

MeSH Terms

Interventions

quinagolide

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

+1 833-548-1402

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 2, 2018
• Study Start: December 26, 2018
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: August 18, 2023
• Results First Posted: August 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (43)