Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01085877
First received: March 11, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.


Condition Intervention Phase
Menopause
Postmenopausal Vaginal Atrophy
Drug: estradiol, 25 mcg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet Formulations Administered in Postmenopausal Women With Vaginal Atrophy

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction [ Time Frame: from dosing to day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events and local tolerability [ Time Frame: from dosing to day 4 ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trial part 1 Drug: estradiol, 25 mcg
Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)
Experimental: Trial part 2 Drug: estradiol, 25 mcg
Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are able to use the German language, spoken and written
  • Postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start
  • Availability of a normal mammogram within 1 year prior to trial start
  • Good general health
  • No significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician

Exclusion Criteria:

  • Known or suspected allergy to estradiol or related products
  • Known, suspected or past history of breast cancer
  • Abnormal genital bleeding
  • Previous oestrogen and/or progestin hormone replacement therapy
  • Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
  • Hot flushes which require systemic hormone replacement treatment
  • Known insulin dependent or non-insulin dependent diabetes mellitus
  • Systolic blood pressure (BP) of more than 160 mm Hg and/or diastolic BP or more than 100 mm Hg, currently treated or untreated
  • Active deep venous thrombosis or thromboembolic disorders or a history of these conditions
  • Active arterial thrombosis or a documented history of this condition
  • Known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results
  • Known HIV infection based on laboratory result
  • Porphyria
  • Body Mass Index (BMI) above 30.0 kg/m2
  • Cervical smear presenting PAP of more than class II
  • Known or suspected vaginal infection requiring further treatment
  • Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
  • Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine
  • Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085877

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01085877     History of Changes
Other Study ID Numbers: VAG-3821, U1111-1113-4908, 2009-017034-50
Study First Received: March 11, 2010
Last Updated: June 25, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 22, 2014