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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486979
First received: December 5, 2011
Last updated: March 19, 2012
Last verified: March 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average plasma concentration (C average) [ Designated as safety issue: No ]
  • Maximal concentration (Cmax) [ Designated as safety issue: No ]
  • Minimal concentration (Cmin) [ Designated as safety issue: No ]
  • Time of maximal concentration (tmax) [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]

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

Ages Eligible for Study:   60 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486979

Locations
Germany
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michaela Eugster-Hausmann Novo Nordisk FemCare AG
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486979     History of Changes
Other Study ID Numbers: VAG-1850, 2006-005957-31
Study First Received: December 5, 2011
Last Updated: March 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 26, 2014