Phase 2
N=67
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT03749109 ↗Enrolled (actual)
67
Serious AEs
1.5%
Results posted
Sep 2022
Primary outcome: Primary: 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 — -0.20; -1.94; 2.41; -0.94 mm — p=0.78
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Quinagolide 1080 µg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-0.20; -1.94; 2.41; -0.94; -3.10; -3.43 | 0.78 |
| SECONDARY Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 |
15.64; -6.83; 7.67; 5.81; -3.04; -6.99 | 0.65 |
| SECONDARY Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4 |
18.9; 21.7; 0; 12.1; 12.1; 24.1 | 0.95 |
| SECONDARY Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4 |
24.0; 31.8; 0; 11.5; 15.0; 37.5 | 0.60 |
| SECONDARY Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4 |
14; 5; 0; 1; 1; 2 | 0.13 |
| SECONDARY Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4 |
2.12; 1.89; -0.15; -0.87 | 0.97 |
| SECONDARY Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4 |
14.19; 4.06 | 0.42 |
| SECONDARY Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4 |
-1.2; -2.1; -1.3; -1.6; -1.5; -1.9 | 0.10 |
| SECONDARY Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4 |
-0.5; -0.7; -0.9; -1.1; -1.7; -1.1 | 0.73 |
| SECONDARY Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4 |
-46.6; -51.0; -56.6; -94.0; -55.6; -41.7 | 0.75 |
| SECONDARY Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration) |
31.9; 32.6; 27.8; 26.9; 28.1; 27.4 | — |
| SECONDARY Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration) |
5.1; 5.1; 5.3; 4.7; 5.3; 5.1 | — |
| SECONDARY Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4 |
5.51; 12.68; 9.30; 12.79; 9.47; 12.31 | — |
| SECONDARY Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4 |
1.672; 1.513; 1.785; 1.509; 1.692; 1.422 | — |
| SECONDARY Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4 |
23.90; 22.96; 19.9; 21.81; 21.82; 20.22 | — |
| SECONDARY Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4 |
11.66; 5.50; 2.90; 2.92; 2.78; 3.16 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Hematocrit |
-0.007; -0.005 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin |
-3.6; -3.2 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin |
-0.7; -0.6 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration |
-3.1; -4.3 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume |
-1.2; -0.7 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Platelets |
4.9; 11.6 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes |
-0.02; -0.01 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Leukocytes |
-0.43; 0.18 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase |
-1.1; -0.2 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Albumin |
0.0; 0.7 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase |
3.1; 4.2 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase |
1.0; 0.5 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate |
-2.7; -2.9 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin |
0.0; 0.0 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Bilirubin |
-1.2; -0.8 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Calcium |
0.009; 0.012 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Chloride |
0.2; -0.5 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Cholesterol |
0.045; 0.244 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Creatinine |
-3.5; -4.3 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase |
-1.1; 1.0 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Glucose |
-0.07; -0.06 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase |
2.7; 2.8 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Phosphate |
-0.013; 0.048 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Potassium |
0.07; 0.06 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Sodium |
0.7; 0.4 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Protein |
-0.1; 1.4 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Urate |
10.7; 1.3 | — |
| SECONDARY Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen |
-0.180; 0.148 | — |
| SECONDARY Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters |
2.86; 0 | — |
| SECONDARY Frequency and Intensity of Adverse Events |
28.6; 43.8; 42.9; 37.5; 2.9; 9.4 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03749109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.