The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms

Pfizer

Status and phase: Completed; Phase 3

Conditions: Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: desvenlafaxine succinate sustained release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401245

3151A2-405

Details and patient eligibility

About

Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated with menopause. Nausea is the most common adverse event that is observed in clinical studies and is the main reason for discontinuation during the first week of therapy. Other adverse events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when subjects abruptly discontinue the medication. The purpose of this study is to evaluate several titration and tapering regimens of DVS SR to ensure a better tolerability profile at the start and completion of treatment. In addition, this study will provide a long posttreatment follow-up to assess any symptoms after treatment is discontinued.

Enrollment: 500 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy, postmenopausal woman who seeks treatment for hot flushes.
• Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH levels >40 mIU/mL.

Exclusion criteria

• History of a seizure disorder other than a single childhood febrile seizure.
• History or presence of clinically important hepatic or renal disease or other medical disease.
• Presence or recent history of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 8 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

B

Active Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

C

Active Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

D

Active Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

E

Active Comparator group

Treatment:

Drug: Placebo

F

Active Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

G

Active Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

H

Placebo Comparator group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release