Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)
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ClinicalTrials.gov Identifier: NCT00332033 |
Recruitment Status
:
Completed
First Posted
: June 1, 2006
Last Update Posted
: July 2, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Leiomyoma Fibroids | Drug: Pirfenidone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 32 participants |
Primary Purpose: | Treatment |
Official Title: | Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids) |
Study Start Date : | May 25, 2006 |
Study Completion Date : | February 16, 2007 |


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Ages Eligible for Study: | 35 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
- Parous and non-parous women who have completed child-bearing (age criteria of greater than 35 years-old, and less than 50 years-old).
- Currently practicing or willing to practice contraception throughout the duration of the study.
- Women with at least one fibroid greater than 4 cm diameter on ultrasound examination.
- Women who were planning to undergo hysterectomy for treatment of symptomatic fibroids may also participate if they are willing to defer the operation until the study is completed. The patients will understand that they may choose to have surgery or any other non-study treatment at any time after enrollment and end study participation.
EXCLUSION CRITERIA:
- Inability to comply with study visits and requirements.
- BMI greater than 33kg/m(2)
- History of a serious adverse reaction to study medication.
- Inability to tolerate MRI and 3D ultrasound procedures (i.e. presence of an intra-uterine device (IUD), pacemakers, aneurismal clips or other metallic devices that are not compatible with magnetic resonance imaging).
- Medical problems including: genetic diseases that cause fibroids, history of thromboembolic (blood clot) events or need for anticoagulation (Coumadin, Heparin, etc.).
- A history of cancer within the past 5 years.
- Abnormal liver function tests (typically, will be greater than 20% elevation). Mild elevations will be at the discretion of the investigators, but undiagnosed liver conditions will represent an exclusion criterion.
- Pregnancy or lactation. Pregnancy will be evaluated by (Beta)hCG test every 30 days. Patients will be asked to use non-hormonal contraception methods while on study drug.
- Severe anemia (hct. Less than 30). Mild anemia is common in women with fibroids.
- Recent rapid growth of fibroids (i.e. doubling in size within one-six months).
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Use any of the following medications:
- Oral, injectable, or inhaled steroids or megesterol within the past year
- Estrogen or progesterone-containing compounds (including oral contraceptives, hormone replacement therapy, transdermal/injectable/vaginal/oral preparations, herbal medications with estrogenic or anti-estrogenic effects) within the past 8-12 weeks; or GnRH analogs (Danazol) or other compounds that affect menstrual cyclicity
- Agents like Imidazoles, due to possible interference with metabolism.
- Unevaluated gynecologic abnormalities (unexplained vaginal bleeding, cervical dysplasia, or abnormal adnexal/ovarian mass).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332033
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Publications:
ClinicalTrials.gov Identifier: | NCT00332033 History of Changes |
Other Study ID Numbers: |
060029 06-CH-0029 |
First Posted: | June 1, 2006 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | February 16, 2007 |
Keywords provided by National Institutes of Health Clinical Center (CC):
Fibroids Leiomyoma Pirfenidone Misoprostol Non-Surgical |
Collagen Uterus Uterine Fibroids Uterine Leiomyoma |
Additional relevant MeSH terms:
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases Pirfenidone |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents |