Back to resultsComparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
Primary Purpose
Menopause, Postmenopausal Vaginal Atrophy
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
estradiol, 25 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 the German language, spoken and written
- Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
- Availability of a normal mammogram within 1 year prior to trial start
- Good general health
- No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician
Exclusion Criteria:
- Known or suspected allergy to estradiol or related products
- Known, suspected or past history of breast cancer
- Abnormal genital bleeding
- Previous oestrogen and/or progestin hormone replacement therapy
- Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
- Hot flushes which require systemic hormone replacement treatment
- Known insulin dependent or non-insulin dependent diabetes mellitus
- Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
- Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
- Active arterial thrombosis or a documented history of this condition
- Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
- Known HIV infection based on laboratory result
- Porphyria
- Body Mass Index (BMI) above 30.0 kg/m2
- Cervical smear presenting PAP of more than class II
- Known or suspected vaginal infection requiring further treatment
- Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
- Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
- Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Trial part 1
Trial part 2
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction
Secondary Outcome Measures
Number of adverse events and local tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01085877
Brief Title
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
Official Title
An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet Formulations Administered in Postmenopausal Women With Vaginal Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (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 compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, 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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial part 1
Arm Type
Active Comparator
Arm Title
Trial part 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
estradiol, 25 mcg
Intervention Description
Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)
Intervention Type
Drug
Intervention Name(s)
estradiol, 25 mcg
Intervention Description
Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)
Primary Outcome Measure Information:
Title
Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction
Time Frame
from dosing to day 4
Secondary Outcome Measure Information:
Title
Number of adverse events and local tolerability
Time Frame
from dosing to day 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are able to use the German language, spoken and written
Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
Availability of a normal mammogram within 1 year prior to trial start
Good general health
No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician
Exclusion Criteria:
Known or suspected allergy to estradiol or related products
Known, suspected or past history of breast cancer
Abnormal genital bleeding
Previous oestrogen and/or progestin hormone replacement therapy
Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
Hot flushes which require systemic hormone replacement treatment
Known insulin dependent or non-insulin dependent diabetes mellitus
Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
Active arterial thrombosis or a documented history of this condition
Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
Known HIV infection based on laboratory result
Porphyria
Body Mass Index (BMI) above 30.0 kg/m2
Cervical smear presenting PAP of more than class II
Known or suspected vaginal infection requiring further treatment
Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
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:
City
Mainz
ZIP/Postal Code
55127
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
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