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

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ClinicalTrials.gov Identifier: NCT01085877
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Menopause Postmenopausal Vaginal Atrophy Drug: estradiol, 25 mcg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : March 2010
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis
U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction [ Time Frame: from dosing to day 4 ]

Secondary Outcome Measures :
  1. Number of adverse events and local tolerability [ Time Frame: from dosing to day 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085877

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01085877     History of Changes
Other Study ID Numbers: VAG-3821
U1111-1113-4908 ( Other Identifier: WHO )
2009-017034-50 ( EudraCT Number )
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

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