Clinical TrialID 7214

The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health

NCT05258513

Sexual Health|Libido

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Record Fields

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Clinical Trial Id
7214
Evidence Id
7214
Core Evidence Id
7214
Source Clinical Trial Id
7204
Herb2 Clinical Trial Id
HBCT007204
Nct Id
NCT05258513
Title
The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
Status
Completed
Phase
Study Result
No
Study Condition
Sexual Health|Libido
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DIETARY_SUPPLEMENT: Placebo Supplementation|DIETARY_SUPPLEMENT: GG sourced from Annatto
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
83
Outcome Measure
Changes in Overall Sexual Function, Assessed by administering the Derogatis Interview for Sexual Functioning (DISF-SR) for subjective measurement. Values range from 0 to 8 with higher scores demonstrating a better outcome., Week 0, 4 and 8|Changes in Aging Male Symptoms, Assessed by administering the Aging Male Symptoms scale to males for subjective measurement. Values range from 1 to 5 with lower scores demonstrating a better outcome., Week 0, 4, and 8|Changes in Androgen Deficiency in Aging Males Scale, Assessed by administering the Androgen Deficiency in Aging Males scale to males for subjective measurement. Values range from 1 to 5 with higher scores demonstrating a better outcome., Week 0, 4, and 8|Changes in Satisfaction to Treatment, Assessed by administering the Erectile Dysfunction Interview for Treatment Satisfaction (EDITS) to males for subjective measurement. Values range from 0 to 4 with lower scores demonstrating a better outcome., Week 4 and 8|Changes in Erection Hardness, Assessed by administering the Erection Hardness Score (EHS) to males for subjective measurement. Values range from 0 to 4 with higher scores demonstrating a better outcome., Week 0, 4 and 8|Changes in Erectile Function, Assessed by administering the International Index of Erectile Function (IIEF) to males for subjective measurement. Values range from 0 to 5 with higher scores demonstrating a better outcome., Week 0, 4 and 8|Changes in Female Sexual Function, Assessed by administering the Female Sexual Function Index to females for subjective measurement. Values range from 0 to 5 with higher scores demonstrating a better outcome., Week 0, 4 and 8|Changes in Hot Flashes, Assessed by administering the Hot Flashes and Night Sweats questionnaire to females for subjective measurement. Values range from 0 to 10 with lower scores demonstrating a better outcome., Week 0, 4 and 8|Changes in Night Sweats, Assessed by administering the Hot Flashes and Night Sweats questionnaire to females for subjective measurement. Values range from 0 to 10 with lower scores demonstrating a better outcome., Week 0, 4 and 8
Sponsor Collaborator
Applied Science & Performance Institute
Funded By
INDUSTRY
Location
Applied Science and Performance Institute, Tampa, Florida, 33607, United States
Other Id
122102
Start Date
2022-02-06
Primary Completion Date
2022-12-09
Completion Date
2022-12-09
First Posted
2022-02-28
Results First Posted
Last Update Posted
2022-12-29
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05258513
Title Cn
Title En
The Effects of Geranylgeraniol (GG) Sourced From Annatto on Sexual Health
Bilingual Status
semi_complete