Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

NCT02887885 | Completed DMC

• 1 other identifier: 2016-00380
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women

Conditions

Atrophy of Vagina; Postmenopause

Outcome Measures

Primary Outcomes (1)

• Mean change in vaginal maturation index (VMI)

  0 weeks, 4 weeks

Secondary Outcomes (6)

• Mean change in VMI

  0 weeks,1 week, 2 weeks, 6 weeks

• Mean change in vaginal pH

  0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks

• Number of lactobacilli

  0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks

• Lactobacillary grade (LBG),

  0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks

• Mean change in the most bothersome moderate and severe symptom of vaginal atrophy (MBS) . The symptoms include dryness, pain/burning sensation, pruritus, discharge, and dyspareunia.

  0 weeks,1 week, 2 weeks, 4 weeks, 6 weeks

Interventions

Gynoflor DRUG

1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

postmenopausal women

You may qualify if:

• Postmenopausal women (last menstrual period more than 12 months ago or having undergone bilateral ovariectomy)
• Age ≥ 18 years
• Diagnosis of moderate to severe vaginal atrophy at screening visit with VMI \< 50% and vaginal pH \> 4.5
• At least one subjective symptom of vaginal atrophy (dryness, pain/burning sensation, pruritus, discharge, dyspareunia) related to a score of ≥ 65 on the visual analogue scale (VAS)
• Indication for vaginal treatment with Gynoflor® (100 million viable L. acidophilus KS 400 and estriol 30 mcg per application) for 6 weeks because of symptomatic vaginal atrophy after menopause: 1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday).
• Informed consent as documented by signature

You may not qualify if:

• Administration of any form of oral/transdermal hormone therapy (HT) or selective estrogen receptor modulators (SERM) or phytoestrogens within 2 months prior to entry into or during the study.
• Any use of over-the-counter vaginal products within 1 week prior to and during entry the study.
• Known hypersensitivity or allergy to the investigational product
• Estrogen dependent malignancy
• Undiagnosed genital bleeding
• Active thromboembolism
• Active vulvovaginal Candidiasis, Trichomonas vaginitis or bacterial vaginitis based on light microscopy of vaginal secretions, vaginal pH, whiff test and KOH preparation
• Active sexually transmitted infections (STI) including herpes simplex viral infection, gonorrhoea and Chlamydia.
• Active urinary tract infection.
• Pessary-users
• Immunocompromised patients including those with human immunodeficiency viral infection, chronic glucocorticoid use or active treatment with immunosuppressive agents
• Severe liver and/or kidney disease
• Diabetes mellitus
• Polyneuropathy
• Skin disease affecting vulva or vagina, e.g. lichen sclerosus

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Medinova AG: collaborator

Study Sites (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital, Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

• Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.

  PMID: 23985562 BACKGROUND

• McEndree B. Clinical application of the vaginal maturation index. Nurse Pract. 1999 Sep;24(9):48, 51-2, 55-6.

  PMID: 10507070 BACKGROUND

Study Officials

• Petra Stute, Prof

  University Hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 2, 2016
• Study Start: January 22, 2018
• Primary Completion: March 19, 2020
• Study Completion: April 10, 2020
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)