Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

Clalit Health Services

Status and phase: Unknown; Phase 2

Conditions: Endometrial Cancer; Endometrial Hyperplasia

Treatments: Drug: activella; Drug: progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00919919

fr003

5340/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Progesterone vaginal tablet

Experimental group

Description:

Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.

Treatment:

Drug: progesterone

Activella

Other group

Description:

Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally

Treatment:

Drug: activella