Clinical Trials

Research and Studies Conducted by Lawley Pharmaceuticals

Lawley Pharmaceuticals is continually engaged in the process of developing and testing new treatment options in its selected therapeutic areas of men's and women's health. Specific areas of interest include andrology, gynaecology, urology and endocrinology.

Studies under way which are currently recruiting patients include:

Women's Health: Collabrative Study: Testosterone Antidepressant Augmentation in Women

Principal Investigators: Assoc Prof Karen K Miller MD Harvard Medical School, Neuroendocrine Unit, Massachusetts General Hospital, Boston, USA.

Status: Recruiting commenced July 2013

This study is an 8-week randomized, placebo-controlled study of the effects of low-dose testosterone vs. placebo in 100 women with SSRI-resistant depression using AndroFeme® testosterone cream. This study is due to commence in July 2013. For further information contact KKMiller@partners.org.

Study Centres: Neuroendocrine Unit, Massachusetts General Hospital, Boston, USA and Butler Hospital, Rhode Island, USA.


A 52 week, double-blind, randomised, placebo-controlled trial to determine the efficacy of testosterone, with and without DHA supplementation in men with Subjective Memory Complaints as a strategy to prevent the development of Alzheimer’s Disease.

Principal Investigators: Professors Ralph Martins and Roger Clarnette, The McCusker Alzheimer Disease Research Foundation, Inc., Perth, Australia.

Study Sponsor : Lawley Pharmaceuticals

Status: Recruiting commenced January 2013

For more information contact The McCusker Alzheimer Disease Research Foundation on +61 8 93474200 or http://www.alzheimers.com.au.


Use of transdermal testosterone cream in IVF pre-treatment and its effect on controlled ovarian stimulation and IVF outcome in poor responder IVF patients: A randomized placebo-controlled trial

Lead Investigators: Dr Shlomi Barak, Melbourne IVF, East Melbourne, Department of Obstetrics and Gynecology, University of Melbourne.

Status: Recruiting commences February 2013

For more information click here.


Pilot Study of the Effects of Testosterone and Oestradiol Therapy Compared to Placebo on Clinical Indicators and Biomarkers of Dry Eye in Post-Menopausal Women

Principal Investigator: Professor Fiona Stapleton, School of Optometry and Vision Science, University of NSW, Sydney, Australia

Status: Completed. Undergoing analysis.

Download Study details, Participant Information and Consent Form


The Role of Testosterone on Aß Deposition of Alzheimer's disease

Status: Protocols in development. Principal Investigator: Professor Ralph Martins, The McCusker Alzheimer Disease Research Foundation, Inc., Perth, Australia.

For more information please click here.


Completed Clinical Trials

The following clinical trials include:

  1. The Pharmacokinetics of AndroForte® Compared With AndroGel® (Testogel®) in Androgen Deficient Men

    Status: Completed - awaiting publication.

  2. The Pharmacokinetics of AndroForte® Compared With AndroGel® (Testogel®) in Androgen Deficient Men
    Gary Wittert, Royal Adelaide Hospital.

    Completed May 2013 Awaiting publication.

  3. Effect of sequential transdermal progesterone cream on endometrium, bleeding pattern, and plasma progesterone and salivary progesterone levels in postmenopausal women.
    Wren BG et al. Climacteric 2000 3:155–160.

    Download Medical Paper (126kb)

  4. Distribution and metabolism of topically applied progesterone in a rat model.
    Waddell B and O'Leary PJ. J Ster Biochem & Mol Biol. 80 (2002) 449–455.

    Download Medical Paper (94kb)

  5. Plasma and saliva concentrations of progesterone in pre- and postmenopausal women after topical application of progesterone cream.
    O'Leary PJ et al. Presented at the Annual Congress of the Australian Menopause Society held in Perth, Australia in October 1997.

    Download Medical Paper (45kb)

  6. Long-term pharmacokinetics and clinical efficacy of ANDROMEN®FORTE 5% cream for androgen replacement in hypogonadal men.
    Handelsman DJ et al. ANZAC Research Institute, Department of Andrology, Concord Hospital, Sydney, 2004.

    Download Medical Paper (1.8mb)

  7. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women.
    Goldstat R et al. Menopause 2003; 10 (5): 390-398.

    Download Medical Paper (355kb)

  8. The pharmacokinetics pilot study of ANDRO-FEME® 1% testosterone cream following two-week, once-daily application in testosterone deficient women.
    Eden JA et al. Presented at the 4th Annual Congress of the Australasian Menopause Society held in Adelaide 5-7th November 2000.

    Download Medical Paper (74kb)

  9. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder.
    El-Hage et al Climacteric 2007; 10: 335–343.

    Download Medical Paper (186kb)

  10. Pharmacokinetics Of Andromen Forte 5% Cream: A Dose Finding Study.
    Kelleher S et al. ANZAC Research Institute, Department of Andrology, Concord Hospital, Sydney, 2002.

    Download Medical Paper (177kb)