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OpenTrials
Completed

NCT Number: NCT01486979

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

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.

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Key information

Conditions

Menopause Postmenopausal Vaginal Atrophy

Age range

60 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neu-Ulm, 89231, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Area under the curve (AUC)

Secondary outcomes

  1. Average plasma concentration (C average)

  2. Maximal concentration (Cmax)

  3. Minimal concentration (Cmin)

  4. Time of maximal concentration (tmax)

  5. Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2011
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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