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Clomiphene

Phase 2

Hypogonadism, Male | Small molecule | Endocrine |Labcorp Holdings Inc.|Last Updated: Nov 18, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Clomiphene · 1 trial · 1 indication

Phase 2 1
NCT03933618Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile FunctionHypogonadism, Male
COMPLETED24 Analytics
PHASE2COMPLETED
Anastrazole and Clomiphene to Evaluate Hypogonadal Symptoms and Erectile Function
Hypogonadism, MaleUnlock trial analytics

Study Endpoints

Primary Endpoints

IIEF (International Index of Erectile Function) Score - Screen
At baseline

15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

IIEF (International Index of Erectile Function) Score - Week 8
Week 8

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

IIEF (International Index of Erectile Function) Score - Week 16
Week 16

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

IIEF (International Index of Erectile Function) Score - Week 24
Week 24

15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75

Secondary Endpoints

Normalized Testosterone - Screen
Baseline
Normalized Testosterone - Week 8
Week 8
Normalized Testosterone - Week 16
Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
anastrazole-clomiphene-placeboOTHERanastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks
anastrazole-placebo-clomipheneOTHERanastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
clomiphene-anastrazole-placeboOTHERclomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks
clomiphene-placebo-anastrazoleOTHERclomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks
placebo-clomiphene-anastrazoleOTHERplacebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks
placebo-anastrazole-clomipheneOTHERplacebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks

Interventions

NameTypeDescription
Anastrozole 1mgDRUG -
Clomiphene Citrate 25mgDRUG -
Placebo - CapDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexMALE
Healthy VolunteersNo

Inclusion Criteria: 1. Men age 18-70 2. Baseline morning Testosterone 150-350 ng/dL x2 3. leutenizing hormone (LH) 1.5-9.2 miU/mL, Follicle stimulation hormone (FSH) 1.6-8.0 miU/mL, Prolactin 4-15 ng/mL 4. Positive Androgen Deficiency in the Aging Male (ADAM) score. A positive score is when an affi...

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