Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Duramed Research )
ClinicalTrials.gov Identifier:
NCT00592839
First received: December 20, 2007
Last updated: July 12, 2013
Last verified: July 2013

December 20, 2007
July 12, 2013
December 2007
February 2009   (final data collection date for primary outcome measure)
Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes [ Time Frame: Baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Mean change in average frequency of awakenings due to hot flashes [ Time Frame: Weekly and from Screening to End of Treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00592839 on ClinicalTrials.gov Archive Site
  • Mean Change in Individual Sleep Parameters on a Three-point Scale [ Time Frame: Baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
    Change= Week 12 weekly average sleep quality score - Baseline weekly average sleep quality score for the intent-to-treat cohort. The sleep quality was derived from the subject self-assessment of sleep quality graded on a three-point scale (3=excellent, 2=good, 1=poor sleep quality)
  • Mean Change in Stanford Sleepiness Scale [ Time Frame: Baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
    Change= Week 12 score - Baseline Score. Daytime sleepiness was derived from the subject self-assessment how they felt at a particular time of day. Subjects rated daytime sleepiness on the 7 point Stanford Sleepiness Scale (1=most alert to 7=sleepiest).
  • Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide). [ Time Frame: From baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
    Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
  • Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin) [ Time Frame: Baseline to End of Treatment (Week 12) ] [ Designated as safety issue: No ]
    Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
  • Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin). [ Time Frame: Baseline to End of Treatment (12 weeks) ] [ Designated as safety issue: No ]
    Change= Week 12 biochemical markers of bone metabolism (Sex Hormone Binding Globulin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
  • Mean change in individual sleep patterns [ Time Frame: Weekly and from Screening to End of Treatment ] [ Designated as safety issue: No ]
  • Mean change in Stanford Sleepiness Scale Scores [ Time Frame: Each study visit and from Screening to End of Treatment ] [ Designated as safety issue: No ]
  • Mean change in average frequency of awakenings due to hot flashes [ Time Frame: Monthly and from Screening to End of Treatment based on monitoring device data ] [ Designated as safety issue: No ]
  • Mean change in bone markers and SHBG [ Time Frame: From baseline to End of Treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women

This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Nocturnal Vasomotor Symptoms
  • Drug: SCE-B
    0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
    Other Names:
    • Synthetic Conjugated Estrogens, B
    • Enjuvia
  • Drug: Placebo
    Matching placebo for 0.3 mg and 0.625 mg tablets
  • Experimental: 1
    0.3 mg SCE-B Daily
    Interventions:
    • Drug: SCE-B
    • Drug: Placebo
  • Experimental: 2
    0.625 mg SCE-B Daily
    Interventions:
    • Drug: SCE-B
    • Drug: Placebo
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
Liu JH, Reape KZ, Hait HI. Synthetic conjugated estrogens-B and postmenopausal nocturnal vasomotor symptoms: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):78-84. doi: 10.1097/AOG.0b013e31823c0145.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Naturally or surgically menopausal
  • Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion Criteria:

  • Any contraindication to hormone therapy
Female
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00592839
DR-ENJ-401
No
Teva Pharmaceutical Industries ( Duramed Research )
Duramed Research
Not Provided
Study Chair: Study Protocol Chair Duramed Research, Inc.
Teva Pharmaceutical Industries
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP