Nocturnal Vasomotor SymptomsPhase 4NCT00592839

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

A Phase 4 study testing SCE-B in people with Nocturnal Vasomotor Symptoms, run by Duramed Research at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Nocturnal Vasomotor Symptoms
What is being tested?: SCE-B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 157 participants
Where: 17 sitesUnited States
Study dates: Dec 2007to Feb 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Any contraindication to hormone therapy

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Duramed Investigational Site
Albuquerque, New Mexico, 87102
Duramed Investigational Site
Anaheim, California, 92801
Duramed Investigational Site
Clearwater, Florida, 33759
Duramed Investigational Site
Cleveland, Ohio, 44122
Duramed Investigational Site
Columbia, South Carolina, 29201
Duramed Investigational Site
Lexington, Kentucky, 40509
Duramed Investigational Site
Lincoln, Nebraska, 68510
Duramed Investigational Site
Louisville, Kentucky, 40291
Duramed Investigational Site
Mayfield Heights, Ohio, 44124
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
Sacramento, California, 95821
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
West Palm Beach, Florida, 33409
Duramed Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Conditions: Nocturnal Vasomotor Symptoms
Being tested: SCE-B, Placebo
Keywords: Nocturnal vasomotor symptoms in postmenopausal women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCE-BDrug
Also called Synthetic Conjugated Estrogens, B, Enjuvia
0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo
PlaceboDrug
Matching placebo for 0.3 mg and 0.625 mg tablets

Study groups in NCT00592839
Study group	Role	What they receive
1	Experimental	0.3 mg SCE-B Daily Receives: Drug: SCE-B; Drug: Placebo
2	Experimental	0.625 mg SCE-B Daily Receives: Drug: SCE-B; Drug: Placebo
3	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort
Measured: Baseline to End of Treatment (Week 12)

Secondary outcomes (5)

Mean Change in Individual Sleep Parameters on a Three-point Scale
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)
Measured: Baseline to End of Treatment (Week 12)
Mean Change in Stanford Sleepiness Scale
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).
Measured: Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
Change= Week 12 biochemical markers of bone metabolism (N-telopeptide) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Measured: From baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
Change= Week 12 biochemical markers of bone metabolism (Osteocalcin) - Baseline biochemical markers of bone metabolism values for the intent-to-treat cohort.
Measured: Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
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.
Measured: Baseline to End of Treatment (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Feb 2009

First posted14 Jan 2008 (estimated)
Study startDec 2007
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nocturnal Vasomotor SymptomsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00592839
Sponsor's protocol ID: DR-ENJ-401
Status last verified: Jul 2013
First submitted: 20 Dec 2007
Last updated: 19 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22183214

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
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RecruitingPhase 4
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All Nocturnal Vasomotor Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of SCE-B on Nocturnal Vasomotor Symptoms in Postmenopausal Women
ClinicalTrials.gov ID: NCT00592839
Acronym / sponsor ID: DR-ENJ-401
Conditions: Nocturnal Vasomotor Symptoms
Keywords: Nocturnal vasomotor symptoms in postmenopausal women
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 14 Jan 2008 (estimated)
Results: Posted 17 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: SCE-B, Drug: Placebo0.3 mg SCE-B Daily
2	Experimental	Drug: SCE-B, Drug: Placebo0.625 mg SCE-B Daily
3	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 30 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Any contraindication to hormone therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCE-BAlso: Synthetic Conjugated Estrogens, B, Enjuvia0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo	Drug	1, 2
PlaceboMatching placebo for 0.3 mg and 0.625 mg tablets	Drug	1, 2, 3

Primary outcome

Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes
Time frame: Baseline to End of Treatment (Week 12)
Change= Week 12 weekly average awakening score - Baseline weekly average awakening score for the intent-to-treat cohort

5 secondary outcomes

Mean Change in Individual Sleep Parameters on a Three-point Scale
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Stanford Sleepiness Scale
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (N-telopeptide).
Time frame: From baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Osteocalcin)
Time frame: Baseline to End of Treatment (Week 12)
Mean Change in Biochemical Markers of Bone Metabolism (Sex Hormone Binding Globulin).
Time frame: Baseline to End of Treatment (12 weeks)

Results and safety

Results posted to the registry on 17 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.3 mg SCE-B Daily	53	51
0.625 mg SCE-B Daily	52	48
Placebo Daily	52	46

Primary outcome: Mean Change in Average Frequency of Awakenings Due to Sleep-time Hot Flashes

Time frame: Baseline to End of Treatment (Week 12). Least squares mean (Standard Error). Unit: Awakenings

Measure	0.3 mg SCE-B Daily n = 52	0.625 mg SCE-B Daily n = 48	Placebo Daily n = 51
Value	-19.54 (1.195)	-20.55 (1.286)	-15.99 (1.234)

Population analysed: Participants analyzed consisted of subjects from the intent-to-treat (ITT) cohort, \[all subjects who were exposed to investigational product therapy,provided baseline "sleep time" hot flash information and "sleep time" hot flash data for at least one post-baseline visit\]. Not all study subjects completed all data elements in their study diaries.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.3 mg SCE-B Daily	0 of 53 (0%)	0 of 53 (0%)	Not reported
0.625 mg SCE-B Daily	0 of 52 (0%)	4 of 52 (7.7%)	Not reported
Placebo Daily	1 of 52 (1.9%)	1 of 52 (1.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22183214Liu 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.

Related trials for Nocturnal Vasomotor Symptoms

Not yet recruiting
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
Recruiting
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
Perimenopause, Postmenopause
Not yet recruiting
ROSA-B: ALAN Exposure and Brain Health in Midlife Women With VMS
Women in the Menopausal Period
RecruitingPhase 4
No More Sleepless Nights in Perimenopause
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Recruiting
JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Protocol Chair study chair

Duramed Research, Inc.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SCE-B in people with Nocturnal Vasomotor Symptoms, run by Duramed Research at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00592839, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.