Hypogonadotropic HypogonadismPhase 2NCT02369796

A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism

A Phase 2 study testing TAK-448 in people with Hypogonadotropic Hypogonadism, run by Takeda at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with hypogonadotropic hypogonadism. Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Hypogonadotropic Hypogonadism
What is being tested?: TAK-448
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2015to Nov 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant has two morning total serum testosterone (ST) concentrations ≤12.0 nmol/L (≤3.46 ng/mL) taken during the Screening period.
Is male and aged 18 to 60 years, inclusive.
Has a body mass index (BMI) between 25.0 and 50.0 kg/m^2, inclusive.
If diagnosed with type II diabetes mellitus (T2DM), has a glycosylated hemoglobin (HbA1c) concentration <12% at Screening and is on a stable dose of up to 4 diabetes therapies (including insulin and/or glucagon-like peptide-1 therapies).
Has a luteinizing hormone (LH) concentration <8 IU/L at Screening.
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.

Who cannot join

Has received any investigational compound within 30 days prior to Screening.
Has received TAK-448 in a previous clinical study, or previous cohort.
Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than T2DM, its complications and associated conditions), which may impact the ability of the participant to participate or potentially confound the study results.
Has a recent history or clinical manifestations of significant cardiovascular disease (CVD) - such as a history of myocardial infarction or stroke in the 6 months preceding the Screening visit or has untreated peripheral arterial disease.
Has a history of hypersensitivity or allergies to any component of the formulation of TAK-448.

Show all 22Show fewer

Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 5 years prior to Screening.
Is required to take excluded medications, supplements, or food products.
Intends to donate sperm during the course of this study or for 12 weeks after the last dose of study drug.
Has clinical evidence of anatomic or pathological hypothalamic/pituitary disease.
Is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-448, or a similar drug in the same class that might interfere with the conduct of the study.
Has a history of cancer (including prostate cancer), with the exception of basal cell carcinoma which has been in remission for at least 5 years prior to Screening.
Has a history of or present prostate disease (including benign prostatic hyperplasia) or prostate-specific antigen (PSA) is >4 ng/mL at Screening.
Has a known history of human immunodeficiency virus infection at Screening.
Is deemed by the study team to have poor peripheral venous access.
Has donated or lost 450 mL or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Screening, or is planning to donate blood for 12 weeks after the last dose of study medication.
Has a Screening or Day -1 abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature of the principal investigator or medically qualified subinvestigator.
Has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2× the upper limits of normal (ULN).
The participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Has had more than two severe hypoglycemic events (requiring third party assistance) within 6 months prior to the Screening Visit.
Has a diagnosis of type 1 diabetes mellitus.
Has a history of diabetic ketoacidosis.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Oxford, Oxfordshire, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: An Open-Label, Phase 2a Study to Evaluate the Pharmacodynamics of Different Dosing Regimens of TAK-448, a Kisspeptin Agonist, in Male Overweight/Obese Participants With Hypogonadotropic Hypogonadism

Read the detailed description

The drug being tested in this study is called TAK-448. TAK-448 is being tested to treat overweight/obese males with hypogonadotropic hypogonadism. This study will look at the effects of TAK-448 on serum testosterone at different doses and different dosing frequencies.

The study will enroll 15 patients. There will be 5 cohorts and participants will be assigned to cohorts in sequential order. Cohorts will be assigned to the following treatment groups:

TAK-448 3 µg once weekly
TAK-448 1 µg once weekly
TAK-448 0.3 µg once weekly
TAK-448 0.3 µg twice weekly
TAK-448 0.1 µg twice weekly

All participants will be administered study drug via SC injection once or twice a week depending on their assigned cohort for four weeks.

This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 32 days. Participants will make multiple visits to the clinic (depending once-weekly or twice-weekly dosing), and will be contacted by telephone 1 week after last dose of study drug for a follow-up assessment.

Conditions: Hypogonadotropic Hypogonadism
Being tested: TAK-448
Keywords: Drug therapy
Medical subject headings: Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-448Drug
TAK-448 solution for subcutaneous injection

Study groups in NCT02369796
Study group	Role	What they receive
TAK-448 3 µg once weekly	Experimental	TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. Receives: Drug: TAK-448
TAK-448 1 µg once weekly	Experimental	TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. Receives: Drug: TAK-448
TAK-448 0.3 µg once weekly	Experimental	TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22. Receives: Drug: TAK-448
TAK-448 0.3 µg twice weekly	Experimental	TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. Receives: Drug: TAK-448
TAK-448 0.1 µg twice weekly	Experimental	TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25. Receives: Drug: TAK-448

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups
Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measured: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups
Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measured: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups
Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measured: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups
Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Measured: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups
Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measured: Day 22 pre-dose
Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group
Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measured: Day 25 pre-dose
Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups
Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measured: Day 22 pre-dose
Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups
Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Measured: Day 25 pre-dose

Secondary outcomes (4)

Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F
AUC(0-∞) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Nov 2015

First posted24 Feb 2015 (estimated)
Study startFeb 2015
Primary completionOct 2015
Study completionNov 2015

Why it stopped: Sponsor decision to terminate the study because the study did not achieve the primary efficacy objective.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypogonadotropic HypogonadismStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02369796
Sponsor's protocol ID: TAK-448-2001
Other IDs: U1111-1162-4892, 2014-002155-25, 14/LO/1950, 2014
Status last verified: Feb 2017
First submitted: 17 Feb 2015
Last updated: 31 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Phase 2a Study to Evaluate the Pharmacodynamics of Different Dosing Regimens of TAK-448, a Kisspeptin Agonist, in Male Overweight/Obese Participants With Hypogonadotropic Hypogonadism
ClinicalTrials.gov ID: NCT02369796
Acronym / sponsor ID: TAK-448-2001
Conditions: Hypogonadotropic Hypogonadism
Keywords: Drug therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision to terminate the study because the study did not achieve the primary efficacy objective.
Enrolment: 15 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Oct 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 24 Feb 2015 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will enroll 15 patients. There will be 5 cohorts and participants will be assigned to cohorts in sequential order. Cohorts will be assigned to the following treatment groups:

TAK-448 3 µg once weekly
TAK-448 1 µg once weekly
TAK-448 0.3 µg once weekly
TAK-448 0.3 µg twice weekly
TAK-448 0.1 µg twice weekly

All participants will be administered study drug via SC injection once or twice a week depending on their assigned cohort for four weeks.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
TAK-448 3 µg once weekly	Experimental	Drug: TAK-448TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 1 µg once weekly	Experimental	Drug: TAK-448TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg once weekly	Experimental	Drug: TAK-448TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
TAK-448 0.3 µg twice weekly	Experimental	Drug: TAK-448TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
TAK-448 0.1 µg twice weekly	Experimental	Drug: TAK-448TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant has two morning total serum testosterone (ST) concentrations ≤12.0 nmol/L (≤3.46 ng/mL) taken during the Screening period.
Is male and aged 18 to 60 years, inclusive.
Has a body mass index (BMI) between 25.0 and 50.0 kg/m^2, inclusive.

Key exclusion criteria (22 listed)

Has received any investigational compound within 30 days prior to Screening.
Has received TAK-448 in a previous clinical study, or previous cohort.
Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than T2DM, its complications and associated conditions), which may impact the ability of the participant to participate or potentially confound the study results.
Has a recent history or clinical manifestations of significant cardiovascular disease (CVD) - such as a history of myocardial infarction or stroke in the 6 months preceding the Screening visit or has untreated peripheral arterial disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-448TAK-448 solution for subcutaneous injection	Drug	TAK-448 0.1 µg twice weekly, TAK-448 0.3 µg once weekly, TAK-448 0.3 µg twice weekly, TAK-448 1 µg once weekly, TAK-448 3 µg once weekly

Primary outcome

Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups
Time frame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups
Time frame: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups
Time frame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups
Time frame: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose
Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups
Time frame: Day 22 pre-dose
Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group
Time frame: Day 25 pre-dose
Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups
Time frame: Day 22 pre-dose
Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups
Time frame: Day 25 pre-dose
Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.

4 secondary outcomes

Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)
Time frame: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F
Time frame: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F
Time frame: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F
Time frame: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-448 3 µg Once Weekly	3	3
TAK-448 1 µg Once Weekly	3	3
TAK-448 0.3 µg Once Weekly	3	3
TAK-448 0.3 µg Twice Weekly	3	3
TAK-448 0.1 µg Twice Weekly	3	3

Primary outcome: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups

Time frame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose. Mean (Standard Deviation). Unit: percent change

Measure	TAK-448 3 µg Once Weekly n = 3	TAK-448 1 µg Once Weekly n = 3	TAK-448 0.3 µg Once Weekly n = 3
Value	1.9 (11.3)	13.5 (24.9)	14.9 (16.3)

Population analysed: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.

Primary outcome: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups

Time frame: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose. Mean (Standard Deviation). Unit: percent change

Measure	TAK-448 0.3 µg Twice Weekly n = 3	TAK-448 0.1 µg Twice Weekly n = 3
Value	-2.8 (3.7)	6.0 (12.3)

Population analysed: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.

Primary outcome: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups

Time frame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose. Mean (Standard Deviation). Unit: percent change

Measure	TAK-448 3 µg Once Weekly n = 3	TAK-448 1 µg Once Weekly n = 3	TAK-448 0.3 µg Once Weekly n = 3
Value	3.55 (9.08)	11.1 (28.0)	7.92 (8.88)

Population analysed: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.

Primary outcome: Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups

Time frame: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose. Mean (Standard Deviation). Unit: percent change

Measure	TAK-448 0.3 µg Twice Weekly n = 3	TAK-448 0.1 µg Twice Weekly n = 3
Value	-9.00 (4.23)	20.5 (5.33)

Population analysed: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 39. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-448 3 µg Once Weekly	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
TAK-448 1 µg Once Weekly	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
TAK-448 0.3 µg Once Weekly	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
TAK-448 0.3 µg Twice Weekly	0 of 3 (0%)	3 of 3 (100%)	Not reported
TAK-448 0.1 µg Twice Weekly	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-448 in people with Hypogonadotropic Hypogonadism, run by Takeda at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups (time frame: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02369796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.