Back to resultsPharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
Primary Purpose
Menopause, Postmenopausal Vaginal Atrophy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
estradiol, 10 mcg
estradiol, 25 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Menopause
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low dose
High dose
Arm Description
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486979
Brief Title
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Postmenopausal Vaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
estradiol, 10 mcg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
estradiol, 25 mcg
Intervention Description
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
Primary Outcome Measure Information:
Title
Area under the curve (AUC)
Secondary Outcome Measure Information:
Title
Average plasma concentration (C average)
Title
Maximal concentration (Cmax)
Title
Minimal concentration (Cmin)
Title
Time of maximal concentration (tmax)
Title
Incidence of adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neu-Ulm
ZIP/Postal Code
89231
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20423242
Citation
Eugster-Hausmann M, Waitzinger J, Lehnick D. Minimized estradiol absorption with ultra-low-dose 10 microg 17beta-estradiol vaginal tablets. Climacteric. 2010 Jun;13(3):219-27. doi: 10.3109/13697137.2010.483297.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Pharmacokinetic Assessment of the Absorption of Estradiol in Postmenopausal Women With Atrophic Vaginitis
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