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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12605000468628
Date of registration:	23/09/2005
Prospective Registration:	No
Primary sponsor:	FemPharm Pty Ltd and/or Acrux DDS Pty Ltd
Public title:	A pharmacokinetic study to assess the comparative bioavailability of 17-B-estradiol from Metered-Dose Transdermal Sprays (MDTS) and Estraderm 50 patches as hormone replacement therapy in postmenopausal women.
Scientific title:	A pharmacokinetic study to assess the comparative bioavailability of 17-B-estradiol from Metered-Dose Transdermal Sprays (MDTS) and Estraderm 50 patches as hormone replacement therapy in postmenopausal women.
Date of first enrolment:	21/02/2000
Target sample size:	12
Recruitment status:	Completed
URL:	https://anzctr.org.au/ACTRN12605000468628.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Pharmacokinetics;
Phase:	Phase 1

Countries of recruitment
Australia

Contacts

Name:	Karen Gard'ner
Address:	Acrux 103-113 Stanley Street West Melbourne VIC 3003 Australia
Telephone:	+61 3 83790100
Email:	karen.gardner@acrux.com.au
Affiliation:

Name:	Andrew Humberstone
Address:	Acrux 103-113 Stanley Street West Melbourne VIC 3003 Australia
Telephone:	+61 3 83790100
Email:	andrew.humberstone@acrux.com.au
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: Healthy post-menopausal women
Exclusion criteria: No exclusion criteria

Age minimum: 18 Years
Age maximum: Not stated
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Menstruation and menopause

Hormone replacement therapy in postmenopausal women;
Hormone replacement therapy in postmenopausal women

Intervention(s)

Estradiol Metered-Dose Transdermal Sprays (MDTS) vs Estraderm 50 patches for 6-days.

Primary Outcome(s)

Pharmacokinetic parameters - serum concentration of estradiol[On day 1 and 6 - 8.]

Secondary Outcome(s)

Safety and Tolerability[]

Secondary ID(s)

Source(s) of Monetary Support

Acrux DDS Pty Ltd

FemPharm Pty Ltd

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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