A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
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ClinicalTrials.gov Identifier: NCT00272935 |
Recruitment Status :
Completed
First Posted : January 9, 2006
Last Update Posted : July 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hot Flashes | Drug: Cenestin 0.3 mg Tablets Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | May 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Cenestin 0.3 mg Tablets
1 tablet daily
Other Name: Synthetic conjugated estrogens, A |
Placebo Comparator: 2 |
Other: Placebo
1 tablet daily
Other Name: Placebo tablets |
- Mean change in average frequency of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ]
- Mean change in severity of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ]
- Safety and tolerability of Cenestin 0.3mg [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272935

Study Chair: | Duramed Research Protocol Chair | Duramed Research, Inc |
Responsible Party: | Duramed Protocol Chair, Duramed Research, Inc. |
ClinicalTrials.gov Identifier: | NCT00272935 |
Other Study ID Numbers: |
BR-CEN-301 |
First Posted: | January 9, 2006 Key Record Dates |
Last Update Posted: | July 3, 2012 |
Last Verified: | July 2009 |
menopause vasomotor symptoms |
Hot Flashes Estrogens Estrogens, Conjugated (USP) Estrogens, conjugated synthetic A |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |