A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196378

Enrollment

300

Registered

2005-09-20

Start date

2004-11-30

Completion date

2006-02-28

Last updated

2013-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain, dyspareunia

Brief 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.

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.

Interventions

DRUGSynthetic Conjugated estrogens, B

1 (0.3mg) tablet daily

OTHERPlacebo

1 tablet daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean change in the symptom identified by the patient to be most bothersome	Randomization to Week 12
Mean change in vaginal pH	Randomization to Week 12
Mean change in maturation index	Randomization to Week 12

Secondary

Measure	Time frame
Safety and tolerability of Enjuvia	Duration of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026