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

NCT01085877 | Completed Phase 1

• 3 other identifiers: VAG-3821U1111-1113-49082009-017034-50
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Postmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction

  from dosing to day 4

Secondary Outcomes (1)

• Number of adverse events and local tolerability

  from dosing to day 4

Study Arms (2)

Trial part 1

ACTIVE COMPARATOR

Drug: estradiol, 25 mcg

Trial part 2

EXPERIMENTAL

Drug: estradiol, 25 mcg

Interventions

estradiol, 25 mcg DRUG

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)

Trial part 1

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Mainz, 55127, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

DE (1)