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

A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272935

Enrollment

400

Registered

2006-01-09

Start date

2005-12-31

Completion date

2007-05-31

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

menopause, vasomotor symptoms

Brief summary

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.

Detailed 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

Interventions

DRUGCenestin 0.3 mg Tablets

1 tablet daily

OTHERPlacebo

1 tablet daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Mean change in average frequency of moderate to severe hot flashes	Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes	Baseline to Day 28 and to Day 84

Secondary

Measure	Time frame
Safety and tolerability of Cenestin 0.3mg	Throughout study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026