A Multicenter, Randomized, Double-Blind, Placebo- And Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated with Menopause

• Conditions: Generally healthy, postmenopausal women of age 40 to 65 seeking treatment for hot flushes with last natural menstrual period (LNMP) completed at least 12 months prior to screening (if LNMP is uncertain, the medical monitor or designee may approve a follicle-stimulating hormone [FSH] level; FSH level > 40 mIU/mL will allow enrollment).

• Registration Number: EUCTR2004-005022-45-FI
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-17
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 465

Inclusion Criteria

1.Generally healthy, postmenopausal women of age 40 to 65 seeking treatment for hot flushes with last natural menstrual period (LNMP) completed at least 12 months prior to screening (if LNMP is uncertain, the medical monitor or designee may approve a follicle-stimulating hormone [FSH] level; FSH level > 40 mIU/mL will allow enrollment).
2.Intact uterus
3.Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening, using the following definitions:·
Mild hot flush: sensation of heat without sweating·
Moderate hot flush: sensation of heat with sweating, able to continue activity·
Severe hot flush: sensation of heat with sweating, causing cessation of activity
4.Subjects must have body mass index (BMI) less than or equal to 34 kg/m2 using the nomograph for BMI
5.In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to venlafaxine (Effexor or Effexor XR) or tibolone
2.History, presence or suspicion of estrogen-dependent neoplasia (including endometrial hyperplasia)
3.Undiagnosed vaginal bleeding
4.Malignancy, or treatment for malignancy, within the previous 2 years, with the exception of basal cell carcinoma of the skin or squamous cell carcinoma of the skin. A history of breast cancer, melanoma, or any gynecologic cancer, at any time, excludes the subject
5.Unresolved breast findings (on physical or imaging examinations) suggestive of malignant changes
6.Unresolved cervical cytology smear report of atypical glandular cells (AGC). Unresolved atypical squamous cells (ASC). Cervical cytologic smear report of low-grade squamous intraepithelial lesion (LSIL), or greater, cervical intraepithelial neoplasia (CIN) I or greater, or any reported dysplasia
7.History of a seizure disorder other than a single childhood febrile seizure
8.Active or recent arterial thromboembolic disease (e.g., myocardial infarction or angina)
9.History of cerebrovascular accident, stroke, or transient ischemic attack
10.History of venous thromboembolism (e.g., deep venous thrombosis, pulmonary embolism)
11.History or presence of clinically important hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject (e.g., clinically important cardiac arrhythmia, clinically important hyponatremia, uncontrolled diabetes, uncontrolled hypertension)
12.Endocrine disease (except for controlled hypothyroidism or diet-controlled diabetes mellitus)
13.Presence of major depressive disorder, bipolar disorder, psychotic disorder or generalized anxiety disorder requiring therapy
14.Gallbladder disease (subjects who have had a cholecystecomy may be enrolled).
15.Persistent elevated blood pressure (greater than 160 mm Hg systolic or greater than 100 mm Hg diastolic). Subjects may not be using more than 2 antihypertensive medications for the treatment of hypertension
16.Known presence of raised intraocular pressure or history of narrow-angle glaucoma
17.Neuro-ocular disorders (e.g., retinal vasculitis)
18.Porphyria
19.Clinically important abnormalities on screening physical examination, electrocardiogram (ECG) or laboratory tests (e.g., fasting total cholesterol greater than 300 mg/dL, fasting triglycerides greater than 300 mg/dL, fasting blood glucose greater than 125 mg/dL, or serum alanine aminotransferase [ALT] or serum aspartate aminotransferase [AST] greater than 1.5 times the upper limit of normal for the laboratory used)
20.Presence of malabsorption disorder
21.Use of oral estrogen-, progestin-, androgen- or selective estrogen receptor modulator (SERM)-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening
22.Use of any investigational drug within 30 days
23.Use of medications thought to relieve VMS within 4 weeks prior to screening, such as aldomet, clonidine, dopaminergic or antidopaminergic drugs (e.g., veralipride), Bellergal (containing belladonna, phenobarbital and ergotamine), gabapentin, he

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified