Endometrial Hyperplasia
Conditions
Keywords
Endometrial Hyperplasia without atypia
Brief summary
The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.
Detailed description
Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.
Interventions
DEVICEIntrauterine Device
Mirena and Provera
Sponsors
Center for Research on Women and Newborn Health
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Histologic diagnosis of simple or complex endometrial hyperplasia without atypia * Normal pap smear within one year
Exclusion criteria
* Diabetes * Family history of endometrial cancer * Contraindications for the intrauterine device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Side effects | 90 days |
| Bleeding profile | 90 days |
| Estradiol and progesterone levels | 90 days |
Outcome results
None listed