Clinical trial NCT01085877: Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Postmenopausal Vaginal Atrophy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction
timeFrame: from dosing to day 4
Secondary outcomes:
measure: Number of adverse events and local tolerability
timeFrame: from dosing to day 4
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: