Uterine Fibroids with Heavy Menstrual Periods
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- STATUS
- Recruiting
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- sponsor
- ObsEva
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.
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
| Condition | Uterine Fibroids |
|---|---|
| Clinical Study Identifier | TX152664 |
| Sponsor | ObsEva |
| Last Modified on | 25 March 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
Learn moreComplete 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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