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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01085877
First received: March 11, 2010
Last updated: June 25, 2014
Last verified: June 2014

March 11, 2010
June 25, 2014
March 2010
May 2010   (final data collection date for primary outcome measure)
Area under the curve (AUC(0-t)), maximal concentration (Cmax) of estradiol after baseline correction [ Time Frame: from dosing to day 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01085877 on ClinicalTrials.gov Archive Site
Number of adverse events and local tolerability [ Time Frame: from dosing to day 4 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Menopause
  • Postmenopausal Vaginal Atrophy
  • 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)
  • Drug: 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)
  • Active Comparator: Trial part 1
    Intervention: Drug: estradiol, 25 mcg
  • Experimental: Trial part 2
    Intervention: Drug: estradiol, 25 mcg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01085877
VAG-3821, U1111-1113-4908, 2009-017034-50
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP