A 12 month, open-label, multi-center trial to investigate the endometrial safety of Vagifem Low Dose (10ug 17beta-estradiol vaginal tablet) in postmenopausal women with atrophic vaginitis symptoms. Trial Phase: IIIa

• Conditions: atrophic vaginitis; MedDRA version: 8.1Level: LLTClassification code 10003690Term: Atrophic vaginitis

• Registration Number: EUCTR2006-001629-24-FI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 530

Inclusion Criteria

1.Informed consent to be obtained before any trial related activities. (Trial related activities are any procedure that would not have been performed during normal management of the subject.)
2.Postmenopausal women aged 45 years or older at the time of screening.
3.Postmenopausal women = 2 years after last menstruation; or bilateral oophorectomy performed 2 years or more prior to the time of screening.
4.Serum FSH levels > 40 mIU/ml and estradiol < 20 pg/ml
5.Subject should have at least 1 urogenital symptom of moderate to severe severity as identified by the subject (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity) during the week prior to screening period.
6.= 5% superficial cells as assessed by evaluation of vaginal cytology
7.Vaginal pH = 5
8.Endometrial thickness < 4.0 mm (double layer), as measured by transvaginal ultrasound.
9.Normal mammogram within 6 months prior to trial start (Visit 1) or normal mammogram prior to Visit 2 if not available at Visit 1.
10.Subject with an intact uterus, meaning no component removed or destroyed. For example patients who have undergone an endometrial ablation or transcervical resection of the endometrium are not eligible to participate.
11.Good general health, as assessed by the Investigator and based on medical history, and physical and laboratory examinations.
12.No significant illnesses that could interfere with the subject’s participation in the trial, based upon Investigator judgment.
13.Able to comply with the requirements of the trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known or suspected allergy to trial product or related products.
2.Known, suspected or past history of breast cancer.
3.Known, suspected or past estrogen dependent neoplasia e.g. endometrial cancer.
4.Endometrial hyperplasia or endometrial polyps diagnosed during the screening period.
5.Abnormal genital bleeding of unknown etiology.
6.Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months prior to the screening visit
7.Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-estrogenic medications including K-Y jelly etc., 1 month prior to Visit 2.
8.Hot flushes which require systemic HT treatment.
9.Known insulin dependent or non-insulin dependent diabetes mellitus.
10.Systolic blood pressure (BP) = 160 mm Hg and/or diastolic BP = 100 mm Hg, currently treated or untreated.
11.Active deep venous thrombosis or thromboembolic disorders or a history of these conditions.
12.Active arterial thrombosis or a documented history of this condition.
13.Known or suspected hepatic and/or renal impairment based on medical history, physical examination, and/or laboratory results.
14.Porphyria.
15.Body Mass Index (BMI)> 35.0 kg/m2.
16.Papanicolaou cervical smear presenting PAP class > II.
17.Known or suspected vaginal infection requiring further treatment.
18.Uterovaginal prolapse Grade II-IV POPQ (pelvic organ prolapse qualification scale).
19.Hysterectomy or endometrial ablation
20.Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day).
21.Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine.
22. Previous participation (i.e., the subject has passed Visit 2) in this trial.
23.Subject who has participated in any other trial involving other investigational products within the last 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified