QLARITY: Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
Study Details
Study Description
Brief Summary
This will be 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Quinagolide 1080 µg Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. |
Drug: Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 µg for daily releases
Other Names:
|
| Placebo Comparator: Placebo Vaginal ring containing matching placebo |
Drug: Placebo
Matching placebo
|
Outcome Measures
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 [At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)]
Secondary Outcome Measures
- 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)]
- Changes in the sizes of endometrioma assessed by transvaginal ultrasound (TVU) at cycle 4 [At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)]
- Changes in the mean individual and total symptom and sign severity of scores of the Biberoglu and Behrman (B&B) scale at cycle 4 [At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)]
B&B scale is a 4-point scale with 0=none and 3=severe.
- Changes in the Numerical Rating Scale (NRS) pain scores per cycle at cycles 1, 2, 3 and 4 [At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)]
Assessed by participants. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain
- Changes in the Endometriosis Health Profile-30 (EHP-30) scores at cycles 2 and 4 [At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)]
EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement
- Changes in the menstrual bleeding pattern over 4 cycles [At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)]
Assessed by patient self-reported answers to menstrual bleeding questions
- Serum levels of prolactin, thyroid-stimulating hormone (TSH), insulin-like growth factor-1 (IGF-1) during cycle 1, at cycles 2 and 4 [Within 1-5 days post randomisation, and at menstrual cycles 2 (~2 months) and 4 (~4 months)]
Assessed by blood sample collection
- Plasma concentrations of quinagolide and its metabolites during cycles 1 to 4 [Within 1-5 days post randomisation, within 7-14 days post randomisation, and at menstrual cycles 1 (~1 months), 2 (~2 months), 3 (~3 months) and 4 (~4 months)]
Assessed by blood sample collection
- Changes in clinical chemistry and hematology parameters with markedly abnormal changes [At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)]
Assessed by blood sample collection
- Proportion of subjects with markedly abnormal changes in clinical chemistry and hematology parameters [At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)]
Assessed by blood sample collection
- Frequency and intensity of adverse events [From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)]
Assessed by and Adverse Event Log completed by the Investigator
Eligibility Criteria
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 randomisation 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gyneacology Rigshospitalet | Copenhagen | Denmark | ||
| 2 | Charité Universitätsmedizin | Berlin | Germany | ||
| 3 | Universitätsklinikum Carl Gustav Carus | Dresden | Germany | ||
| 4 | Universitätsklinikum Münster | Münster | Germany | ||
| 5 | Azienda Opsedaliera Universitaria Careggi | Florence | Italy | ||
| 6 | Università degli Studi di Roma La Sapienza | Rome | Italy | ||
| 7 | Azienda Ospedaliera Universitaria Senese | Siena | Italy | ||
| 8 | Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | ||
| 9 | Centrum Medyczne PROMED | Kraków | Poland | ||
| 10 | Gabinet Lekarski Specjalistyczny SONUS | Warsaw | Poland | ||
| 11 | Specjalistyczny Gabinet Lekarski | Warsaw | Poland |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Global Clinical Compliance, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 000295