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OpenTrials
Completed

NCT Number: NCT02542410

Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study

The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent, cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of endometriosis-associated pain in young women with endometriosis.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgically confirmed endometriosis
  • Age between 15-40 y, and premenopausal
  • Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

Exclusion criteria

  • Use of other concurrent hormone medications (such as birth control pills)
  • Impaired liver function (ALT > 2x normal) or liver disease (cirrhosis, hepatitis)
  • Pregnancy
  • Breast cancer
  • Active thromboembolic disease
  • Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders

Treatment and study plan

cabergoline

Drug

Other names: Dostinex

Norethindrone acetate

Drug

Other names: Aygestin

Primary outcomes

  1. Change in Score in Worst Pain Over the Last Month

    Time frame: Baseline, 6 months

    visual analog scale, minimum=0 and maximum=10 Higher numbers are a worse outcome

    Outcome measures is calculated as the value at 6 months minus value at baseline.

Secondary outcomes

  1. Changes in Pain Interference Scores

    Time frame: Baseline, 6 months

    Brief Pain Inventory Interference subscale is a 7-item self-report measure, designed to assess the extent to which pain interferes with various components of functioning, including physical and emotional functioning and sleep.The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items is used as a measure of pain interference (i.e., how much a participant's pain interferes with her ability to complete activities of daily living and functioning). The score on the pain interference subscale ranges from 0-70. Higher scores are worse outcomes.

    Outcome measure calculated as the value at 6 months minus the value at baseline

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2015
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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