Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

Inclusion Criteria:

- Pre-menopausal females aged ≥18 years at time of signing informed consent(s).

- Body mass index (BMI) of 18-38 kg/m2 (both inclusive) at screening.

- Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10
years before the run-in visit.

- Transvaginal ultrasound documenting a uterus with no clinically significant
abnormalities and presence of at least one ovary with no clinically significant
abnormalities (e.g. no evidence of endometrioma greater than 3 cm in diameter) at the
run-in visit.

- Having moderate to severe endometriosis-related pain.

- Willing to use a non-hormonal barrier method (i.e. condom) for contraception from
randomization to the end-of-trial. This is not required if adequate contraception is
achieved by vasectomy of the sexual partner or surgical sterilisation of the subject.

- Willing to avoid the use of vaginal douches or any other intravaginally administered
medications or devices from randomization to the end of treatment.

- Willing to change usual analgesics to rescue analgesics as permitted by protocol for
endometriosis-related pain from the start of run-in to the end-of-trial.

Exclusion Criteria:

- Use of depot medroxyprogesterone acetate (MPA) within 10 months of the start of
run-in.

- Use of gonadotropin releasing hormone (GnRH) agonists (3 months depot) or dopamine
agonists within 6 months of the start of run-in.

- Use of GnRH agonists (1 month depot) or intrauterine device within 3 months of the
start of run-in.

- Use of GnRH antagonist, combined oral contraceptive pill or progestin-only pill within
1 month of the start of run-in.

- Undiagnosed abnormal vaginal bleeding.

- History of no relief of endometriosis related pain after any medical therapy or
surgery. However, history of partial pain relief, discontinuation due to side effects
are not exclusionary.

- Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting
bone resorption or bone formation markers.

- Any significant abnormal findings of heart examinations before randomization.