Fibroids/Endometriosis

Last updated: October 18, 2023
Sponsor: Myovant Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

TX320594
  • Ages 18-50
  • Female

Study Summary

Open-Label study to evaluate bone mineral density with long-term use of combination tablet birth control in premenopausal women with heavy menstrual bleeding associated with uterine fibroids or moderate to severe pain associated with endometriosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Premenopausal woman 18-50 years old
  • A diagnosis of uterine fibroids
  • A diagnosis of endometriosis
  • No Metabolic bone disease
  • No history of inflammatory bowel disease or gastric bypass surgery
  • No history of breast cancer
  • No history of organ transplantation

Study Design

Study Start date:
October 11, 2023
Estimated Completion Date:

Study Description

The estimated duration of the study will be approximately 60 months (5 yrs.) in addition to the screening which is 42 days. In office visits and phone calls will occur every 3 months for a total of 10 in office visits and 9 phone call visits, plus 3 end of study follow-up phone call visits. While on study the participant will be required to complete offsite visits to our study specific locations for (4) Mammograms, (11) DXA scans (bone density imaging) and (1) Gynecological Exam.

Connect with a study center

  • Elite Clinical Studies, LLC

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

    0.52 miles

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