Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01085877
First received: March 11, 2010
Last updated: March 19, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause Postmenopausal Vaginal Atrophy |
Drug: estradiol, 25 mcg |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Menopause
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Number of adverse events and local tolerability [ Time Frame: from dosing to day 4 ] [ Designated as safety issue: Yes ]
| Enrollment: | 70 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Trial part 1 |
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)
|
| Experimental: Trial part 2 |
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)
|
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01085877 History of Changes |
| Other Study ID Numbers: | VAG-3821, U1111-1113-4908, 2009-017034-50 |
| Study First Received: | March 11, 2010 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Atrophy Pathological Conditions, Anatomical Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 19, 2013