A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes

Duramed Research

Status and phase: Completed; Phase 3

Conditions: Hot Flashes

Treatments: Other: Placebo; Drug: Cenestin 0.3 mg Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00272935

BR-CEN-301

Details and patient eligibility

About

This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.

Full description

The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets

Enrollment: 400 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naturally or surgically postmenopausal
• At least 12 months since last menses or 6 weeks past surgery
• Minimum of 7 daily or 50 weekly moderate to severe hot flashes

Exclusion criteria

• Any contraindication to natural or synthetic estrogens

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Cenestin 0.3 mg Tablets

2

Placebo Comparator group

Treatment:

Other: Placebo