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Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486979
First Posted: December 7, 2011
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to to evaluate the extent of systemic absorption of estradiol during treatment with two different doses of estradiol in postmenopausal women with atrophic vaginitis.

Condition Intervention Phase
Menopause Postmenopausal Vaginal Atrophy Drug: estradiol, 10 mcg Drug: estradiol, 25 mcg Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Weekly Maintenance Therapy in Postmenopausal Women With Atrophic Vaginitis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the curve (AUC)

Secondary Outcome Measures:
  • Average plasma concentration (C average)
  • Maximal concentration (Cmax)
  • Minimal concentration (Cmin)
  • Time of maximal concentration (tmax)
  • Incidence of adverse events

Enrollment: 58
Study Start Date: January 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose Drug: estradiol, 10 mcg
One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
Active Comparator: High dose Drug: estradiol, 25 mcg
One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are able to use German language in speaking and writing
  • Postmenopausal women with at least 5 years after last menstruation, or bilateral oophorectomy performed two years or more prior to the time of screening
  • Serum FSH (Follicle Stimulating Hormone) levels above 40 mIU/ml and estradiol below 20 pg/ml
  • Maximum 5% superficial cells as assessed by evaluation of vaginal cytology
  • Endometrial thickness below 4.0 mm (double layer), as measured by transvaginal ultrasound (if applicable)
  • Availability of a normal mammogram within one year prior to trial start
  • Good general health as assessed by the Investigator and based on medical history, and physical and laboratory examinations

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Known, suspected or past history of breast cancer
  • Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer
  • Endometrial hyperplasia or endometrial polyps diagnosed during the screening period
  • Abnormal genital bleeding of unknown etiology
  • Previous estrogen and/ or progestin hormone replacement therapy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01486979


Locations
Germany
Novo Nordisk Investigational Site
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486979     History of Changes
Other Study ID Numbers: VAG-1850
2006-005957-31 ( EudraCT Number )
First Submitted: December 5, 2011
First Posted: December 7, 2011
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Atrophy
Vaginitis
Atrophic Vaginitis
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female


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