Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis

NCT03749109 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 000295
• Study Type: interventional
• Target: 67
• Locations: 4 countries
• Sites: 11

Brief Summary

This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.

Conditions

Endometriosis

Keywords

Endometrioma; Adenomyosis; Deep infiltrating endometriosis

Outcome Measures

Primary Outcomes (1)

• Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4

  The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.

  At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

Secondary Outcomes (45)

• Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

  At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

• Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4

  At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

• Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4

  At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

• Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4

  At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

• Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4

  At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

Study Arms (2)

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 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 - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
• Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
• Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
• Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
• Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment

You may not qualify if:

• Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
• Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
• Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
• Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
• Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (11)

Gyneacology Rigshospitalet

Copenhagen, Denmark

Location

Charité Universitätsmedizin

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Azienda Opsedaliera Universitaria Careggi

Florence, Italy

Location

Università degli Studi di Roma La Sapienza

Rome, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Centrum Medyczne PROMED

Krakow, Poland

Location

Gabinet Lekarski Specjalistyczny SONUS

Warsaw, Poland

Location

Specjalistyczny Gabinet Lekarski

Warsaw, Poland

Location

Related Publications (1)

• Pellicer A, Taylor HS, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta KE, Pinton P, Heiser PW, Bagger YZ. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113946. doi: 10.1016/j.ejogrb.2025.113946. Epub 2025 Mar 30.

  PMID: 40188683 DERIVED

MeSH Terms

Conditions

Endometriosis; Adenomyosis

Interventions

quinagolide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Diseases

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

-

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: November 19, 2018
• First Posted: November 21, 2018
• Study Start: August 19, 2019
• Primary Completion: June 21, 2021
• Study Completion: July 18, 2021
• Last Updated: August 7, 2023
• Results First Posted: September 7, 2022

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (3); PL (3); IT (4)