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

Phase 1

Completed

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

• Registration Number: NCT01085877
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trial part 1	estradiol, 25 mcg	-
Trial part 2	estradiol, 25 mcg	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction	from dosing to day 4

Secondary Outcome Measures

Name	Time	Method
Number of adverse events and local tolerability	from dosing to day 4