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 - QLARITY

Ferring Pharmaceutical A/S0 sites67 target enrollmentJanuary 28, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Ferring Pharmaceutical A/S
Enrollment: 67
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 28, 2021

End Date

July 18, 2021

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Ferring Pharmaceutical A/S

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.