Endometrial Cancer, Endometrial Hyperplasia
Conditions
Keywords
menopause, Endometrial Thickness, progesterone
Brief summary
The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
Detailed description
Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.
Interventions
DRUGprogesterone
Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month
DRUGactivella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Sponsors
Ferring Pharmaceuticals
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms. * Women with an intact uterus. * No menses within the 12 months preceding screening visit and /or FSH \>30 IU/L. * Endometrial thickness ≤ 5 mm.
Exclusion criteria
* Submucosal fibroid/s that applying pressure and affecting endometrial thickness * Other medication that could affect estrogenic state.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the proportion of bleeding pattern between the two groups. | 1 year |
| To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire. | 1 year |
Countries
Israel
Contacts
Primary ContactAviva Kaplan
Outcome results
None listed