UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy of the hyaluronic acid preparations (hyaluprotect) for the atrophic changes due to aging in the vagina and vulva.
Title of the study (Brief title)	Study of the efficacy of the hyaluprotect for the atrophic vagina due to aging.
Region	Japan

Condition
Condition	Atrophic changes due to aging of vagina and vulva.
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the efficasy of a hyaluronan product "hyaluprotect" to the atrophic changes due to aging of vagina and vulva.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sujjective symptoms and Vaginal Vestibule Maturation Value after 2,4 and 6 weeks.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	A hyaluronic acid preparation (hyaluprotect) 2-4 weeks
Interventions/Control_2	estriol vaginal tablet 2-4 weeks
Interventions/Control_3	moistjelly 2-4 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Menopausal for more than six months due to physiological or surgical reason. Complaint of dryness in the vagina. Atrophic findings in the vulva.
Key exclusion criteria	No contraindication of estriol. No bacterial infection. No use of other external medication for vagina within one week. No use of systemic estrogen within one month.
Target sample size	40

Research contact person
Name of lead principal investigator	Sakie Niwa
Organization	Sakie ladies clinic
Division name	director
Address	Hakubi Ikeshita Bild 3F 2-15 Ikeshita Chikusa Nagoya Japan
TEL	052-757-0222
Email	info@tclinic.jp

Public contact
Name of contact person	Mototsugu Fukaya
Organization	Tsurumai Kouen Clinic
Division name	director
Address	5-20-6 Chiyoda Nakaku Nagoya
TEL	052-164-0212
Homepage URL
Email	moto@earth.ocn.ne.jp

Sponsor
Institute	Sakie ladies clinic
Institute
Department

Funding Source
Organization	Fukaya corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 28 Day
Anticipated trial start date	2016 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 06 Day
Last modified on	2019 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024124