A study to evaluate the effect of quinagolide extended-release vaginal ring on reduction of lesions, assessed by high-resolution MRI, in women with endometrioma, deep inflitrating endometriosis and/or adenomyosis.
- Conditions
- Deep infiltrating endometriosis, endometrioma and/or adenomyosisMedDRA version: 21.0Level: LLTClassification code 10014787Term: Endometriosis of uterusSystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-000915-26-IT
- Lead Sponsor
- Ferring Pharmaceutical A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 67
1. Informed consent signed and dated prior to any trial-related procedures.
2. In good physical and mental health to participate in the trial.
3. Pre-menopausal females between the ages of 18-45 years (both inclusive) at the time of signing the informed consent.
4. A menstrual cycle of 24-35 days (both inclusive) based on observation made in the absence of drugs that can affect the cycle length (e.g. oral contraceptives) prior to the screening visit.
5. Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening.
6. Confirmation of deep infiltrating endometriosis (DIE) (lesion size =15 mm), endometrioma ( =20 mm) or adenomyosis (maximum junctional zone thickness =12 mm or focal lesion =15 mm) by high-resolution MRI at screening.
7. Transvaginal ultrasound 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.
8. Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-oftreatment. 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).
9. 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.
10. Documentation of normal cervical cytology or negative human papilloma virus (HPV) results for high-risk viral subtypes upon presence of atypical squamous cells of undetermined significance, based on test(s) performed within 24 months of randomisation.
11. Willing and able to comply with trial procedures, including attending scheduled visits and adherence to treatment plan.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Use of depot medroxyprogesterone acetate (MPA) or birth control implants (e.g.IMPLANON) 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, 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. Undiagnosed abnormal vaginal bleeding within the last 3 months of the screening visit.
6. History of recurrent bacterial, fungal or viral vaginal infection (i.e. =4 episodes within a y).
7. History of malignancy within 5 ys prior to the screening visit, except for adequately
managed basal cell carcinoma and squamous cell carcinoma of the skin.
8. History of orthostatic hypotension or recurrent syncope.
9. History of mental illness including occurrence of acute psychosis and bipolar schizophrenia
(except for well-controlled mild or moderate anxiety and/or depression with no changes to
interventions for 3 months prior to the screening visit).
10. History of sudden sleep onset episodes.
11. Known diagnosis of impulse control disorders including pathological gambling, compulsive
buying, hypersexuality, and binge eating.
12. Known positive results of Human Immunodeficiency Virus antibody tests.
13. Any other incidental, clinically significant abnormal findings than endometriotic /
adenomyotic lesions identified at the screening MRI assessment (e.g. suspected tumour).
14. Any clinically significant abnormal findings from vital signs, blood tests of haematology and clinical chemistry at screening, including alanine aminotransferase (ALT)>2.5 times (ULN) or bilirubin>1.5 times ULN or creatinine>1.5 times ULN.
15. Any clinically significant abnormal findings at physical examination at screening.
16. Any vaginal or vulvar lesions that would interfere with vaginal ring usage.
17. Current pregnancy as confirmed by a positive serum pregnancy test at screening or planning
a pregnancy within the duration of the trial, or currently breast-feeding or less than 6 months post-partum prior to the screening visit.
18. Planned surgical treatment of endometriosis or adenomyosis during the duration of the trial.
19. Continuous use of strong opioids (e.g. morphine) and/or illicit drugs (e.g. marijuana and
amphetamine) for more than 2 weeks within 6 months prior to the screening visit.
20. Alcohol abuse (>14 units of alcohol/week) within 2 ys prior to the screening visit.
21. Previous or current participation in a clinical trial involving a nonregistered
Investigational medicinal product within 1 month of screening. If the trial involves a
hormonal drug, the exclusion criteria 1-4 shall apply.
22. Contraindications to MRI
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method