A Study to Assess the Quinagolide Vaginal Ring for Endometriosis-related Pain

Overview

About this study

The purpose of this study is to evaluate the effectiveness of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate-to-severe endometriosis-related pain

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Pre-menopausal females aged ≥ 18 years at time of signing informed consent(s). 
  • Body mass index (BMI) of 18-42 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 sterilization 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Tatnai Burnett, M.D.

Open for enrollment

Contact information:

Maureen Lemens R.N.

(507)293-1487

Lemens.Maureen@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20468263

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