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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

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