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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085877
• Other study ID #: VAG-3821
• Secondary ID: U1111-1113-49082
• Status: Completed
• Phase: Phase 1
• First received: March 11, 2010
• Last updated: June 25, 2014
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Menopause
• Postmenopausal Vaginal Atrophy

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction		from dosing to day 4	No
Secondary	Number of adverse events and local tolerability		from dosing to day 4	Yes

External Links

•   Clinical Trials at Novo Nordisk