Uterine Fibroids with Heavy Menstrual Periods

  • STATUS
    Recruiting
  • sponsor
    ObsEva
Updated on 25 March 2021

Summary

Uterine Fibroids with Heavy Menstrual Periods

Description

Northern California Research is conducting a study for uterine fibroids with heavy menstrual bleeding. Uterine fibroids (myoma) are harmless (benign), hormone-sensitive, smooth muscle tumors of the uterus. They are the most common tumor of the female reproductive tract in premenopausal women and are usually not noticeable. Uterine fibroids affect approximately 4 out of 10 women between the ages of 35 and 55. Fibroids can cause heavy menstrual bleeding, abdominal pressure, abdominal pain, increased urinary frequency, and infertility. Today, uterine fibroids are usually treated by surgery; however, depending on the extent of the surgery, this may cause infertility.

We are seeking FDA approval for a new medication to asses if it is safe and can reduce heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The study is double-blind, meaning that neither you nor your study doctor/staff will know which study drug you will receive. You will be randomized into one out of 5 different study medication groups: You have an equal chance of being in any of the 5 study groups. There’s a 20% chance that you will only receive placebo. "Add-back" is a FDA approved medication, E2-Neta, provided to help with possibly bone density loss.

  • Placebo plus placebo add-back (100 subjects)
  • 100 mg study medication plus placebo add-back (100 subjects)
  • 100 mg study medication plus add-back (low dose) (100 subjects)
  • 200 mg study medication plus placebo add-back (100 subjects)
  • 200 mg study medication plus add-back (standard dose)

    In order to participate you must have a regular menstrual cycle, discontinue any hormonal birth control therapies and undergo an endometrial biopsy. You will be required to collect your used sanitary products and return to the site within the specific time period. The study sponsor will also provide all necessary sanitary items. The study is a year and 8 months long. It includes 13 office visits. All trial-related visits, tests, and medications will be provided to you at no cost. In addition, reimbursement for trial-related time and travel may be provided.

  • Details
    Clinical Study IdentifierTX152664
    SponsorObsEva
    Last Modified on25 March 2021

    Eligibility

    Yes No Not Sure

    Inclusion Criteria

    Premenopausal females 18 years or older
    Has regular menstrual cycles that are 21 to 40 days apart
    recalls having experienced abnormal heavy menstrual bleeding (heavy or lasting more than 5 days) for the past 6 months

    Exclusion Criteria

    Body mass index (BMI) >40
    Previous history or current diagnosis of HIV, AIDS, Hep B, Hep C
    condition is so severe that she will require surgery within 6 months regardless of the treatment provided
    history of or current uterine, cervical, ovarian, breast cancer or any estrogen- dependent neoplasia
    severe coagulation disorder (e.g. hemophilia or Von Willebrand disease)
    Participated in an investigational trial within the past 3 months
    Clear my responses

    How to participate?

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    What happens next?
    • You can expect the study team to contact you via email or phone in the next few days.
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    Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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    If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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    Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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