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Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Jundiai, Sao Paulo, 13209-000 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hot Flashes, Sleep Disorders
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Intact uterus

- Generally health postmenopausal women 45 to 60 years of age, inclusive

- Sexually active

- No hormone replacement therapy within the 90 days immediately prior to the screening
evaluation.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Known or suspect estrogen-dependent neoplasia

- Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle

- Use of any estrogen, progestin, androgen containing medications or tibolone within 12
weeks before screening.

NCT00195520
Pfizer
Completed
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

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Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hot Flashes
  • Sleep Disorders
Drug: Totelle®
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2006
Not Provided

Inclusion Criteria:

  • Intact uterus
  • Generally health postmenopausal women 45 to 60 years of age, inclusive
  • Sexually active
  • No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.

Exclusion Criteria:

  • Known or suspect estrogen-dependent neoplasia
  • Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
  • Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.
Sexes Eligible for Study: Female
45 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00195520
0753T-101537
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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