A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy
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ClinicalTrials.gov Identifier: NCT00196378 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : September 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menopause | Drug: Synthetic Conjugated estrogens, B Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 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 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 |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Synthetic Conjugated estrogens, B
1 (0.3mg) tablet daily
Other Name: Enjuvia |
Placebo Comparator: 2 |
Other: Placebo
1 tablet daily |
- 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 ]
- Safety and tolerability of Enjuvia [ Time Frame: Duration of 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
- Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Exclusion Criteria:
- 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

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): NCT00196378

Study Chair: | Duraemd Protocol Chair | Duramed Research, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Duramed Protocol Chair, Duramed Research, Inc. |
ClinicalTrials.gov Identifier: | NCT00196378 History of Changes |
Other Study ID Numbers: |
DR-ENJ-301 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | September 2, 2013 |
Last Verified: | January 2010 |
vaginal atrophy vaginal dryness vaginal itching vaginal pain dyspareunia |
Atrophy Pathological Conditions, Anatomical Estrogens Estrogens, Conjugated (USP) Estrogens, conjugated synthetic A |
Estrogens, conjugated synthetic B Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |