Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

ASCEND Therapeutics

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Symptoms

Treatments: Drug: Estrogel; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160173

S166.4.003

Details and patient eligibility

About

This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

Full description

The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Enrollment: 221 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women 45-65 years
• naturally or surgically postmenopausal
• experiencing hot flushes

Exclusion criteria

• hypersensitivity to estrogen replacement therapy
• pregnancy or lactating
• abnormal PAP smear
• history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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221 participants in 3 patient groups, including a placebo group

EstroGel® Gel 0.9 grams 0.03%

Experimental group

Description:

0.9 g of EstroGel® 0.03% applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.

Treatment:

Drug: Estrogel

EstroGel® Gel 1.25 grams 0.03%

Experimental group

Description:

1.25 g of EstroGel® 0.03% applied to one arm and 0.9 g of placebo gel applied on the other arm once daily for 12 weeks.

Treatment:

Drug: Estrogel

Placebo Gel

Placebo Comparator group

Description:

0.9 g of placebo gel applied to one arm and 1.25 g of placebo gel applied on the other arm once daily for 12 weeks.

Treatment:

Other: Placebo