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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Quinagolide 1080 µg
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometrioma, Adenomyosis, Deep infiltrating endometriosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
  2. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
  3. Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
  4. Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
  5. 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)
  6. 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

Exclusion Criteria:

  1. Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
  2. Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
  3. 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.
  4. Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
  5. Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)

Sites / Locations

  • Gyneacology Rigshospitalet
  • Charité Universitätsmedizin
  • Universitätsklinikum Carl Gustav Carus
  • Universitätsklinikum Münster
  • Azienda Opsedaliera Universitaria Careggi
  • Università degli Studi di Roma La Sapienza
  • Azienda Ospedaliera Universitaria Senese
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Centrum Medyczne PROMED
  • Gabinet Lekarski Specjalistyczny SONUS
  • Specjalistyczny Gabinet Lekarski

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quinagolide 1080 µg

Placebo

Arm Description

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

Vaginal ring containing matching placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on 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.
Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on 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.
Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on 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.
Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on 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.
Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on 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.
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15.
Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: during the last menstrual cycle during the menstrual period of the last menstrual cycle during the non-menstrual period of the last menstrual cycle
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.
Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Platelets
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Albumin
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Calcium
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Chloride
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Creatinine
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Glucose
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Phosphate
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Potassium
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Sodium
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Protein
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Urate
Assessed by blood sample collection
Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
Assessed by blood sample collection
Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
Assessed by blood sample collection
Frequency and Intensity of Adverse Events
Assessed by and Adverse Event Log completed by the Investigator

Full Information

First Posted
November 19, 2018
Last Updated
August 4, 2023
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03749109
Brief Title
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
Acronym
QLARITY
Official Title
A Randomised, 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
July 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometrioma, Adenomyosis, Deep infiltrating endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quinagolide 1080 µg
Arm Type
Experimental
Arm Description
Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vaginal ring containing matching placebo
Intervention Type
Drug
Intervention Name(s)
Quinagolide 1080 µg
Other Intervention Name(s)
FE 999051
Intervention Description
Vaginal ring containing Quinagolide 1080 µg for daily releases
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Secondary Outcome Measure Information:
Title
Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Description
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
Description
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
Description
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Description
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
Description
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
Description
Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
Description
B&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs. In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3. In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3. The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E. The score can be between 0 and 15.
Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Title
Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
Description
Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes: during the last menstrual cycle during the menstrual period of the last menstrual cycle during the non-menstrual period of the last menstrual cycle
Time Frame
At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Title
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
Description
EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.
Time Frame
At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
Title
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
Description
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.
Time Frame
At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Title
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
Description
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.
Time Frame
At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Title
Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
Description
Assessed by blood sample collection
Time Frame
Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Title
Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
Description
Assessed by blood sample collection
Time Frame
Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Title
Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
Description
Assessed by blood sample collection
Time Frame
Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Title
Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
Description
Assessed by blood sample collection
Time Frame
Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Title
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Platelets
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Albumin
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Calcium
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Chloride
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Creatinine
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Glucose
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Phosphate
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Potassium
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Sodium
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Protein
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Urate
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
Description
Assessed by blood sample collection
Time Frame
At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Title
Frequency and Intensity of Adverse Events
Description
Assessed by and Adverse Event Log completed by the Investigator
Time Frame
From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Gyneacology Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Charité Universitätsmedizin
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Azienda Opsedaliera Universitaria Careggi
City
Florence
Country
Italy
Facility Name
Università degli Studi di Roma La Sapienza
City
Rome
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
Country
Italy
Facility Name
Centrum Medyczne PROMED
City
Kraków
Country
Poland
Facility Name
Gabinet Lekarski Specjalistyczny SONUS
City
Warsaw
Country
Poland
Facility Name
Specjalistyczny Gabinet Lekarski
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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