Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes

Bayer

Status and phase: Completed; Phase 4

Conditions: Hot Flashes

Treatments: Drug: Climara PRO (Estradiol / Levonorgestrel transdermal); Drug: Menostar (Estradiol transdermal); Drug: Placebo transdermal

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206622

308261

91429

Details and patient eligibility

About

To determine the lowest effective dose of estradiol by comparing E2/LNG (2.2mg/0.69mg) and E2 (1.0mg) dose with placebo in decreasing the frequency and severity of moderate to severe hot flushes in postmenopausal women

Full description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Enrollment: 425 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Menopause
• Reporting a minimum of 7 moderate to severe hot flushes per day for at least 1 week (7 consecutive days), or a minimum of 50 moderate to severe hot flushes per week for at least 1 week (7 consecutive days)

Exclusion criteria

• Hormonal treatment
• Contraindication to estrogen/progestogen therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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425 participants in 3 patient groups, including a placebo group

Arm 1

Active Comparator group

Treatment:

Drug: Climara PRO (Estradiol / Levonorgestrel transdermal)

Arm 2

Active Comparator group

Treatment:

Drug: Menostar (Estradiol transdermal)

Arm 3

Placebo Comparator group

Treatment:

Drug: Placebo transdermal