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Trial record 87 of 103 for:    "Kennedy disease"

Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density

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ClinicalTrials.gov Identifier: NCT03264651
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
GTx
Information provided by (Responsible Party):
Havah Therapeutics Pty Ltd

Brief Summary:
To evaluate the impact of a selective androgen receptor modulator combined with an aromatase inhibitor in reducing high mammographic breast density.

Condition or disease Intervention/treatment Phase
Mammographic Density Drug: enobosarm Phase 1

Detailed Description:

High mammographic breast density is a well recognized risk factor for the development of breast cancer and the masking of malignancy within the breast. Previous chemoprevention studies have revealed that only tamoxifen is efficacious in premenopausal women in the reduction of breast cancer. In order for this to occur mammographic density has to be reduced. Unfortunately the side effect profile of tamoxifen is such that not many women are taking up this therapeutic intervention. This trial is trying to establish a combination therapy to reduce mammographic breast density.

This phase 1 pilot study is combining oral enobosarm, a selective androgen receptor modulator, and oral anastrozole, an aromatase inhibitor, to study the impact of this combination treatment on mammographic breast density and breast elasticity. Safety and tolerability we also analyzed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single armed group of premenopausal women receiving open labeled medication
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Centre Pilot Trial Investigating the Efficacy and Safety of Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
Drug Information available for: Anastrozole

Arm Intervention/treatment
Experimental: oral enobosarm and anastrozole
9 mg of oral enbosarm and 1 mg of anastrozole daily
Drug: enobosarm
Oral combination therapy of enobosarm and anastrozole
Other Name: anastrozole




Primary Outcome Measures :
  1. Mammographic breast density [ Time Frame: 12 months ]
    Volumetric analysis of fibroglandular density change on mammography utilizing Volpara software

  2. Breast tissue elasticity [ Time Frame: 1 month ]
    Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

  3. Breast tissue elasticity [ Time Frame: 3 months ]
    Evaluation of breast elasticity change by direct shear wave ultrasonic measurement

  4. Breast tissue elasticity [ Time Frame: 6 months ]
    Evaluation of breast elasticity change by direct shear wave ultrasonic measurement


Secondary Outcome Measures :
  1. Breast pain scale [ Time Frame: 1 month, 3 months, 12 months ]
    Breast pain measured on a 100 mm visual analog scale

  2. Serum gonadotropin levels [ Time Frame: 1 month, 3 months, 12 months ]
    serum follicular stimulating hormone and luteinizing hormone levels

  3. Menopausal symptoms [ Time Frame: 3 months, 12 months ]
    Menopause symptoms as recorded on a menopause symptoms scale



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Pre-menopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, oestrogen) according to the definition of "pre-menopausal range" for the laboratory involved
  • Have a Volpara Density volumetric breast density of >15.5% (combined average both breasts)
  • Breast pain in the previous month of equal to or greater than 40mm on a 100mm visual analogue pain scale
  • WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L.
  • AST/SGOT or ALT/SGPT ≤ 3 times ULN
  • eGFR> 60 ml/min/1.73m2
  • Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment;
  • For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception during and for at least 6 months after completion of study treatment; OR, a fertile male partner willing and able to use effective non-hormonal means of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least 6 months after completion of study treatment;

Exclusion Criteria:

  • Presence of breast cancer
  • Diabetes mellitus or glucose intolerance defined as a fasting glucose >6mmol/l
  • Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years (other than skin cancer)
  • History of coronary artery disease
  • Systemic hormonal contraception
  • Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood
  • Known hypersensitivity to any component of testosterone
  • Unable to comply with study requirements
  • Prolonged systemic corticosteroid treatment
  • Any investigational drugs
  • Systemic hormone replacement therapy
  • Pregnant or lactating women
  • Known liver disease
  • Current warfarin usage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264651


Locations
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Australia, South Australia
Wellend Health
Toorak Gardens, South Australia, Australia, 5065
Sponsors and Collaborators
Havah Therapeutics Pty Ltd
GTx
Investigators
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Principal Investigator: Stephen N Birrell, MD PhD Havah Therapeutics Pty Ltd

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Responsible Party: Havah Therapeutics Pty Ltd
ClinicalTrials.gov Identifier: NCT03264651     History of Changes
Other Study ID Numbers: CH02ST1
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Havah Therapeutics Pty Ltd:
Selective androgen receptor modulator
Aromatase inhibitor

Additional relevant MeSH terms:
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Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs