Clinical trial: Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis (NCT03749109)

Eligibility criteria:
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 randomisation 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)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Contradiction