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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486979
• Other study ID #: VAG-1850
• Secondary ID: 2006-005957-31
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2011
• Last updated: February 6, 2017
• Start date: January 2007
• Est. completion date: May 2007

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Menopause
• Postmenopausal Vaginal Atrophy
• Vaginitis

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)
Secondary	Average plasma concentration (C average)
Secondary	Maximal concentration (Cmax)
Secondary	Minimal concentration (Cmin)
Secondary	Time of maximal concentration (tmax)
Secondary	Incidence of adverse events

External Links

•   Clinical Trials at Novo Nordisk