MenopausePhase 3NCT00361569

A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

A Phase 3 study testing DR-2041a and DR-2041b in people with Menopause, run by Duramed Research at 97 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

This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on 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?: DR-2041a and DR-2041b
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 622 participants
Where: 97 sitesUnited States
Study dates: Aug 2006to Sep 2007
Phase: Phase 3
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 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Naturally or surgically menopausal
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 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

97 sites in 1 country.

City, postcode or hospital

97 sites in 1 country

United States97 sites

Duramed Investigational Site
Albuquerque, New Mexico, 87102
Duramed Investigational Site
Allentown, Pennsylvania, 18104
Duramed Investigational Site
Alpharetta, Georgia, 30005
Duramed Investigational Site
Atlanta, Georgia, 30342
Duramed Investigational Site
Augusta, Georgia, 30901
Duramed Investigational Site
Austin, Texas, 78748
Duramed Investigational Site
Austin, Texas, 78759
Duramed Investigational Site
Baltimore, Maryland, 21224
Duramed Investigational Site
Carmichael, California, 95608
Duramed Investigational Site
Charleston, South Carolina, 29401
Duramed Investigational Site
Charleston, South Carolina, 29425-0100
Duramed Investigational Site
Chicago, Illinois, 60611
Duramed Investigational Site
Chicago, Illinois, 60612
Duramed Investigational Site
Cincinnati, Ohio, 45236
Duramed Investigational Site
Clearwater, Florida, 33756
Duramed Investigational Site
Clearwater, Florida, 33759
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, 43205
Duramed Investigational Site
Columbus, Ohio, 43212
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Corpus Christi, Texas, 78414
Duramed Investigational Site
Dallas, Texas, 75390-9032
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Douglasville, Georgia, 30134
Duramed Investigational Site
Evansville, Indiana, 47714
Duramed Investigational Site
Fresno, California, 93710
Duramed Investigational Site
Gainesville, Florida, 32607
Duramed Investigational Site
Houston, Texas, 77015
Duramed Investigational Site
Houston, Texas, 77024
Duramed Investigational Site
Houston, Texas, 77030
Duramed Investigational Site
Houston, Texas, 77074
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Jacksonville, Florida, 32207
Duramed Investigational Site
Jamestown, North Dakota, 58401
Duramed Investigational Site
Johnson City, New York, 13790
Duramed Investigational Site
King of Prussia, Pennsylvania, 19406
Duramed Investigational Site
Las Vegas, Nevada, 89146
Duramed Investigational Site
Lawrenceville, New Jersey, 08648
Duramed Investigational Site
Lebanon, New Hampshire, 03756
Duramed Investigational Site
Leesburg, Florida, 34748
Duramed Investigational Site
Lexington, Kentucky, 40509
Duramed Investigational Site
Lincoln, Nebraska, 68510
Duramed Investigational Site
Livonia, Michigan, 48152
Duramed Investigational Site
Louisville, Kentucky, 40291
Duramed Investigational Site
Madisonville, Kentucky, 42431
Duramed Investigational Site
Mayfield Heights, Ohio, 44124
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Media, Pennsylvania, 19063
Duramed Investigational Site
Memphis, Tennessee, 38120
Duramed Investigational Site
Miami, Florida, 33143
Duramed Investigational Site
Minot, North Dakota, 58701
Duramed Investigational Site
Mobile, Alabama, 36608
Duramed Investigational Site
Montgomery, Alabama, 36608
Duramed Investigational Site
Moorestown, New Jersey, 08057
Duramed Investigational Site
Nashville, Tennessee, 37203
Duramed Investigational Site
New Brunswick, New Jersey, 08901
Duramed Investigational Site
New London, Connecticut, 06320
Duramed Investigational Site
Newport News, Virginia, 23602
Duramed Investigational Site
Overland Park, Kansas, 66215
Duramed Investigational Site
Philadelphia, Pennsylvania, 19107
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Phoenix, Arizona, 85015
Duramed Investigational Site
Phoenix, Arizona, 85031
Duramed Investigational Site
Phoenix, Arizona, 85032
Duramed Investigational Site
Pinellas Park, Florida, 33781
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
Portland, Oregon, 97210
Duramed Investigational Site
Portland, Oregon, 97239
Duramed Investigational Site
Pueblo, Colorado, 81001
Duramed Investigational Site
Raleigh, North Carolina, 27607
Duramed Investigational Site
Rosemont, Pennsylvania, 19010
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92103
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
San Diego, California, 92123
Duramed Investigational Site
San Ramon, California, 94583
Duramed Investigational Site
Sandy Springs, Georgia, 30328
Duramed Investigational Site
Shreveport, Louisiana, 71106
Duramed Investigational Site
Spokane, Washington, 99207
Duramed Investigational Site
Strafford, Pennsylvania, 19087
Duramed Investigational Site
Stuart, Florida, 34996
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tampa, Florida, 33606
Duramed Investigational Site
Tampa, Florida, 33607
Duramed Investigational Site
Tucson, Arizona, 85710
Duramed Investigational Site
Venice, Florida, 34292
Duramed Investigational Site
Waco, Texas, 76712
Duramed Investigational Site
Warwick, Rhode Island, 02886
Duramed Investigational Site
Watertown, South Dakota, 57201
Duramed Investigational Site
West Palm Beach, Florida, 33407
Duramed Investigational Site
West Palm Beach, Florida, 33409
Duramed Investigational Site
Weston, Florida, 33331
Duramed Investigational Site
Williamsville, New York, 14221
Duramed Investigational Site
Williston, Vermont, 05495
Duramed Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

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: DR-2041a, DR-2041b, Placebo
Keywords: vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain

What participants receive

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

DR-2041aDrug
Also called Synthetic conjugated estrogens, A
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
DR-2041bDrug
Also called Synthetic conjugated estrogens, A
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
PlaceboOther
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
PlaceboOther
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Study groups in NCT00361569
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: DR-2041a
2	Experimental	Not described Receives: Drug: DR-2041b
3	Placebo comparator	Not described Receives: Other: Placebo
4	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
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Measured: Baseline to Week 12
Mean Change in Vaginal pH
Change= Week 12 vaginal pH - Baseline vaginal pH
Measured: Baseline to Week 12
Mean Change in Maturation Index
Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)
Measured: Baseline to Week 12

Secondary outcomes (1)

Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)
Any adverse event reported from the beginning of the 28-day screening through the subject's last report.
Measured: Up to Week 12

Timeline

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

Aug 2006Sep 2007

First posted8 Aug 2006 (estimated)
Study startAug 2006
Primary completionSep 2007
Study completionSep 2007

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 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: 622 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00361569
Sponsor's protocol ID: DR-CEN-302
Status last verified: Mar 2015
First submitted: 3 Aug 2006
Last updated: 20 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.
PubMed 19252451

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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women
ClinicalTrials.gov ID: NCT00361569
Acronym / sponsor ID: DR-CEN-302
Conditions: Menopause
Keywords: vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 622 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Aug 2006
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 8 Aug 2006 (estimated)
Results: Posted 14 Apr 2009

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: DR-2041a
2	Experimental	Drug: DR-2041b
3	Placebo comparator	Other: Placebo
4	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 menopausal
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 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
DR-2041aAlso: Synthetic conjugated estrogens, A1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Drug	1
DR-2041bAlso: Synthetic conjugated estrogens, A2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Drug	2
Placebo1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter	Other	3
Placebo2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter	Other	4

Primary outcome

Mean Change in the Symptom Identified by the Patient to be Most Bothersome
Time frame: Baseline to Week 12
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Mean Change in Vaginal pH
Time frame: Baseline to Week 12
Change= Week 12 vaginal pH - Baseline vaginal pH
Mean Change in Maturation Index
Time frame: Baseline to Week 12
Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)

1 secondary outcome

Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)
Time frame: Up to Week 12

Results and safety

Results posted to the registry on 14 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DR-2041a	150	138
DR-2041b	161	150
Placebo-a	155	137
Placebo-b	156	135

Primary outcome: Mean Change in the Symptom Identified by the Patient to be Most Bothersome

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	DR-2041a n = 135	DR-2041b n = 146	Placebo-a n = 140	Placebo-b n = 135
Value	-1.71 (0.0087)	-1.77 (0.085)	-1.11 (0.086)	-1.10 (0.087)

Population analysed: Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints

Primary outcome: Mean Change in Vaginal pH

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: pH

Measure	DR-2041a n = 135	DR-2041b n = 146	Placebo-a n = 140	Placebo-b n = 135
Value	-1.48 (0.073)	-1.44 (0.071)	-0.31 (0.072)	-0.38 (0.073)

Population analysed: Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints

Primary outcome: Mean Change in Maturation Index

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: Index

Measure	DR-2041a n = 135	DR-2041b n = 146	Placebo-a n = 140	Placebo-b n = 135
Value	31.46 (1.221)	33.27 (1.191)	5.16 (1.205)	8.91 (1.222)

1 secondary outcome is 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 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DR-2041a	1 of 150 (0.7%)	34 of 150 (22.7%)	Not reported
DR-2041b	1 of 161 (0.6%)	36 of 161 (22.4%)	Not reported
Placebo-a	1 of 155 (0.6%)	18 of 155 (11.6%)	Not reported
Placebo-b	3 of 156 (1.9%)	33 of 156 (21.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19252451Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.

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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.

Duramed Protocol Chair study chair

Duramed Research, Inc.

97 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 DR-2041a and DR-2041b in people with Menopause, run by Duramed Research at 97 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 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 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?

Yes. Results are posted in the registry (first posted 14 Apr 2009). 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 the Symptom Identified by the Patient to be Most Bothersome (time frame: Baseline 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 NCT00361569, 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 20 Apr 2015.