Pharmacokinetic Assessment of the Absorption of Estradiol... | NCT01486979

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

NCT01486979

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 8, 2017Estimated

Enrollment

58Actual

Phase

Phase 1

Conditions

Menopause
Postmenopausal Vaginal Atrophy

Interventions

estradiol, 10 mcg
estradiol, 25 mcg

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-005957-31	EudraCT Number

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

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2017

Last Update Posted Date

Feb 8, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose	Experimental		Drug: estradiol, 10 mcg
High dose	Active Comparator		Drug: estradiol, 25 mcg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
estradiol, 10 mcg	Drug	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

Measure	Description	Time Frame
Area under the curve (AUC)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Neu-Ulm		89231	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20423242	Result	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.

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Measure	Description	Time Frame
Average plasma concentration (C average)
Maximal concentration (Cmax)
Minimal concentration (Cmin)