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

NCT01486979 | Completed Phase 1

• 2 other identifiers: VAG-18502006-005957-31
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Postmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC)

Secondary Outcomes (5)

• Average plasma concentration (C average)

• Maximal concentration (Cmax)

• Minimal concentration (Cmin)

• Time of maximal concentration (tmax)

• Incidence of adverse events

Study Arms (2)

Low dose

EXPERIMENTAL

Drug: estradiol, 10 mcg

High dose

ACTIVE COMPARATOR

Drug: estradiol, 25 mcg

Interventions

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

Low dose

estradiol, 25 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

High dose

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neu-Ulm, 89231, Germany

Location

Related 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.

  PMID: 20423242 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 7, 2011
• Study Start: January 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

DE (1)