MenopausePhase 3NCT00196378
A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
A Phase 3 study testing Synthetic Conjugated estrogens, B in people with Menopause, run by Duramed Research at 38 sites in United States.
Trial summary
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Synthetic Conjugated estrogens, B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 38 sitesUnited States
- Study dates
- Nov 2004to Feb 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Naturally or surgically postmenopausal
- Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Who cannot join
- Known sensitivity or contraindication to estrogens or progestins
- History or current diagnosis of endometrial hyperplasia
- Recent history of vaginal bleeding of unknown cause
- Recent history or diagnosis of endometriosis
- Any contraindication to estrogen therapy
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Duramed Investigational Site
Alpharetta, Georgia, 30005
Duramed Investigational Site
Baton Rouge, Louisiana, 70808
Duramed Investigational Site
Billings, Montana, 59101
Duramed Investigational Site
Boise, Idaho, 83712
Duramed Investigational Site
Carmichael, California, 95608
Duramed Investigational Site
Clarksville, Tennessee, 37043
Duramed Investigational Site
Cleveland, Ohio, 44122
Duramed Investigational Site
Colorado Springs, Colorado, 80909
Duramed Investigational Site
Columbia, South Carolina, 29201
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Denver, Colorado, 80202
Duramed Investigational Site
Evansville, Indiana, 47714
Duramed Investigational Site
Fort Worth, Texas, 76104
Duramed Investigational Site
Gainesville, Florida, 32607
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Las Vegas, Nevada, 89109
Duramed Investigational Site
Las Vegas, Nevada, 89128
Duramed Investigational Site
Las Vegas, Nevada, 89146
Duramed Investigational Site
Laurel, Maryland, 20707
Duramed Investigational Site
Mayfield Heights, Ohio, 44124
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Memphis, Tennessee, 38120
Duramed Investigational Site
Miami, Florida, 33143
Duramed Investigational Site
Miami, Florida, 33186
Duramed Investigational Site
Newport News, Virginia, 23602
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92103
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
Sarasota, Florida, 34239
Duramed Investigational Site
Spokane, Washington, 99207
Duramed Investigational Site
Sugarland, Texas, 77478
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tucson, Arizona, 85712
Duramed Investigational Site
Venice, Florida, 34285
Duramed Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
Read the detailed description
The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.
- Conditions
- Menopause
- Being tested
- Synthetic Conjugated estrogens, B, Placebo
- Keywords
- vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain, dyspareunia
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Conjugated estrogens, BDrug
Also called Enjuvia
1 (0.3mg) tablet daily
PlaceboOther
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Synthetic Conjugated estrogens, B |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the symptom identified by the patient to be most bothersome
Measured: Randomization to Week 12
Mean change in vaginal pH
Measured: Randomization to Week 12
Mean change in maturation index
Measured: Randomization to Week 12
Secondary outcomes (1)
Safety and tolerability of Enjuvia
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Duraemd Protocol Chair, Study chair, Duramed Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196378
- Sponsor's protocol ID
- DR-ENJ-301
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2005
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3.
PubMed 18053998
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00196378
- Acronym / sponsor ID
- DR-ENJ-301
- Conditions
- Menopause
- Keywords
- vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain, dyspareunia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
Detailed description
The study will include a screening period up to 4 weeks and a 12-week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Synthetic Conjugated estrogens, B |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Naturally or surgically postmenopausal
- Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Key exclusion criteria (5 listed)
- Known sensitivity or contraindication to estrogens or progestins
- History or current diagnosis of endometrial hyperplasia
- Recent history of vaginal bleeding of unknown cause
- Recent history or diagnosis of endometriosis
- Any contraindication to estrogen 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 |
|---|---|---|
| Synthetic Conjugated estrogens, BAlso: Enjuvia1 (0.3mg) tablet daily | Drug | 1 |
| Placebo1 tablet daily | Other | 2 |
Primary outcome
Mean change in the symptom identified by the patient to be most bothersome
Time frame: Randomization to Week 12
Mean change in vaginal pH
Time frame: Randomization to Week 12
Mean change in maturation index
Time frame: Randomization to Week 12
1 secondary outcome
Safety and tolerability of Enjuvia
Time frame: Duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
- Derived from this study: PubMed 18053998Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. doi: 10.1016/j.fertnstert.2007.07.1359. Epub 2007 Dec 3.
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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.
Duraemd Protocol Chair study chair
Duramed Research, Inc.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Synthetic Conjugated estrogens, B in people with Menopause, run by Duramed Research at 38 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 5 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 2 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the symptom identified by the patient to be most bothersome (time frame: Randomization to Week 12). The study lists 3 primary outcomes in all. 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 NCT00196378, 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 2 Sep 2013.