Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000462280
Ethics application status
Approved
Date submitted
3/06/2009
Date registered
16/06/2009
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Date results information initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative pharmacokinetics and pharmcodynamics of recombinant and urinary human chorionic gonadotrophin (rhCG vs uhCG)
Scientific title
A two part study to compare the pharmacological effects of recombinant human chorionic gonadotrophin (rhCG/Ovidrel) versus urinary human chorionic gonadotrophin (uhCG/Pregnyl) given as subcutaneous injection to healthy men following supression of endogenous testosterone (T) and luteinising hormone (LH) with nandrolone decanoate(ND).
Secondary ID [1] 296748 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Comparative pharmacological effects of two different preparations of human chorionic gonadotrophin (hCG) in men 236905 0
Condition category
Condition code
Metabolic and Endocrine 237259 237259 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: a randomised single dose two phase cross over study. 10 healthy men will receive intramuscular (IM) nandrolone decanoate (ND) 200mg on day 0. Then will be randomised to recieve 1500iu subcutaneous (s/c) injection of either rhCG (Ovidrel) or uhCG (Pregnyl) on day 3/week one followed by s/c rhCG or uhCG on day 10/ week 2 (crossover design).
IM Nandrolone decanoate injections will be repeated on days 4 (100mg), 7 (200mg) and 11 (100mg).
Part 2: a parallel (two) group, multi-dose study
16 healthy men will be recruited into the study.
After consent is provided, each participant will undergo suppression of endogenous T levels prior to and during gonadotrophin treatment by administration of a 200mg intramuscular injections of ND. IM Nandrolone decanoate injections will be repeated on days 5 (100mg), 7 (200mg) and 12 (100mg). After the first ND injection, men will be randomised to receive either Pregnyl 1500iu or Ovidrel 1500iu by subcutaneous injection on days 3, 5, 7 and 10.

All participants will have a single 5ml blood sample taken for Deoxyribonucleic acid (DNA) analysis in order to investigate genetic predictors of variable responses to hCG.
Intervention code [1] 236694 0
Treatment: Drugs
Comparator / control treatment
Part 1: 10 participants will act as their own controls in the cross over study as each one will receive both treament options in a random order.
Part 2: 16 participants will be randomised to receive multiple doses of either rhCG or uhCG and comparisons made between the 2 groups. IM Nandrolone will be administered on days 0, 5, 7 and 10.
Control group
Active

Outcomes
Primary outcome [1] 238072 0
To compare the pharmacokinetic (serum hCG) and pharmacodynamic (serum testosterone) effect of each hCG product in a single dose, cross over randomised sequence, clinical trial in healthy men who have temporary supression of endogenous luteinising hormone (LH) and testosterone (T) in order to observe the pharmacology of the two hCG products on serum testosterone concentrations in the abscence of endogenous testosterone.
Timepoint [1] 238072 0
Blood samples will be collected at baseline and then on the morning of days 3, 4, 5, 6, 7, 10, 11, 12, 13, 14 and 17.
Secondary outcome [1] 242265 0
To evaluate the effect of multiple (4) doses of each hCG product on the pharmacokinetics (serum hCG) and pharmacokinetics (serum T) levels in a randomised, parallel group clinical trial of healthy men undergoing supression of endogenous LH and T using nandrolone.
Timepoint [1] 242265 0
Blood samples will be taken at baseline and then on each morning of days 3, 4, 5, 6, 7, 10, 11, 12, 13, 14 and 17.

Eligibility
Key inclusion criteria
Healthy men over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of:
1. Chronic disease or condition requiring regular medical treatment,
2. Male infertility or pituitary-testicular dysfunction
3. Androgen (anabolic steriod) use or abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to entry into the study, potential participants are assessed for eligibility and required to provide written consent on the approved form.

The men will be informed of the study’s objectives and overall requirements. A study investigator will explain the study using the Participant Information Sheet and Informed Consent Form and participants will be provided with a copy of the Information and Consent forms. If the man is willing to participate in the study, he will be required to give written consent, which will be witnessed by the investigator.

Treatment allocation will be done using opaque, sealed, numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment to treatment group will be determined according to a computer generated randomisation list prepared by an investigator not directly involved with the hormone administration or blood sampling in the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Treatment is open and unblinded in both studies as all pharmacological endpoints are based on objective measures (serum hormone assays) that are undertaken by scientists unaware of treatment assignment and using assays that cannot be influenced by their or the nurses knowledge of treatment.
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
2/09/2009
Date of last participant enrolment
Anticipated
Actual
1/12/2009
Date of last data collection
Anticipated
Actual
18/12/2009
Sample size
Target
26
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 237090 0
Self funded/Unfunded
Name [1] 237090 0
Country [1] 237090 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital (CRGH)
Address
Hospital Road
Concord
NSW 2139
Country
Australia
Secondary sponsor category [1] 4627 0
None
Name [1] 4627 0
Address [1] 4627 0
Country [1] 4627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239191 0
Sydney South Western Area Health Service (SSWAH), Hospital Research Ethics Committee HREC, Concord Hospital
Ethics committee address [1] 239191 0
Building 75
Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord
NSW 2139
Ethics committee country [1] 239191 0
Australia
Date submitted for ethics approval [1] 239191 0
20/05/2009
Approval date [1] 239191 0
20/06/2009
Ethics approval number [1] 239191 0
09/CRGH/87

Summary
Brief summary
There are currently 2 forms of injectable hCG available in Australia. One is derived from urine (Pregnyl) and the other is genetically engineered (Ovidrel). hCG is used to treat men and women with certain types of infertility. However only Pregnyl is available for use in males. If Pregnyl is withdrawn from the market then there will no alternative form of treatment for infertile men.
We aim to compare the action of both forms of hCG in healthy males to determine if Ovidrel has the same pharmacological effects as Pregnyl, when given to men.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 29685 0
Prof David Handelsman
Address 29685 0
Department of Andrology
Building 22
Hospital Road
Concord Repatriation General Hospital
CONCORD NSW 2139
Country 29685 0
Australia
Phone 29685 0
+61 02 97677222
Fax 29685 0
Email 29685 0
djh@anzac.edu.au
Contact person for public queries
Name 12932 0
Professor David Handelsman
Address 12932 0
Anzac Research Institute
Hospital Road
Concord NSW 2139
Country 12932 0
Australia
Phone 12932 0
+61 2 9767 9100
Fax 12932 0
+61 2 9767 7221
Email 12932 0
djh@anzac.edu.au
Contact person for scientific queries
Name 3860 0
Professor David Handelsman
Address 3860 0
Anzac Research Institute
Hospital Road
Concord
NSW 2139
Country 3860 0
Australia
Phone 3860 0
+61 2 9767 9100
Fax 3860 0
+61 2 9767 7221
Email 3860 0
djh@anzac.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.