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Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study


Phase 2
45 Years
60 Years
Not Enrolling
Female
Endometrial Hyperplasia, Endometrial Cancer

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Trial Information

Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Boris Kaplan, prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rabin Medical Center Beilinson Hospital

Authority:

Israel: Ministry of Health

Study ID:

fr003

NCT ID:

NCT00919919

Start Date:

June 2009

Completion Date:

November 2010

Related Keywords:

  • Endometrial Hyperplasia
  • Endometrial Cancer
  • menopause
  • Endometrial Thickness
  • progesterone
  • Endometrial Neoplasms
  • Endometrial Hyperplasia
  • Hyperplasia
  • Adenoma

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