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

Phase 1

Completed

• Conditions: Menopause; Postmenopausal Vaginal Atrophy
• Interventions: Drug: estradiol, 10 mcg; Drug: estradiol, 25 mcg

• Registration Number: NCT01486979
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	estradiol, 10 mcg	-
High dose	estradiol, 25 mcg	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC)

Secondary Outcome Measures

Name	Time	Method
Average plasma concentration (C average)
Maximal concentration (Cmax)
Minimal concentration (Cmin)
Time of maximal concentration (tmax)
Incidence of adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neu-Ulm, Germany