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Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

Primary Purpose

Female Sexual Arousal Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Tribulus Terrestris
Placebo treatment
Sponsored by
Kern Pharma, S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Sexual Arousal Disorder

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
  • Post-menopause.
  • Age between 45 and 65 years.
  • Sexually active.
  • Agreement to participate and to sign the informed consent documents.

Exclusion Criteria:

  • Pregnancy.
  • Women who are on hormone replacement therapy or who need to start it.
  • Cancer treatment or a recent history of cancer (<2 years).
  • Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible)
  • Fibromyalgia.
  • Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.).
  • Any comorbidity that may interfere with the pathology under study.

Sites / Locations

  • CAP Manso
  • Fundació Puigvert
  • Hospital Clínic, Barcelona
  • Sexology InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active group

Control group

Arm Description

One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months.

One tablet per day in the morning through oral administration of Placebo. During three months.

Outcomes

Primary Outcome Measures

Changes of Score on the Female Sexual Function Index (FSFI)
Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido. The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome. Scale subdomains, their scoring range and factor to the total score is the following: Domain: Desire, Range [1 - 5] Factor: 0.6 Domain: Arousal, Range [0 - 5] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range [0 (or 1) - 5 ] Factor: 0.4 Domain: Pain Range [0-5] Factor: 0.4

Secondary Outcome Measures

Variations in testosterone levels (total, bioavailable, and free)
Testosterone levels (total, bioavailable and free) in blood
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.
Score on the Cervantes Scale on quality of life. The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
Number of adverse events
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
Compliance with treatment - Measured with the Morisky-Green scale
The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1. Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0.
Compliance with treatment - Recount of refounded product by patient.
Recount of product returned at the end of study
Compliance with treatment -Therapeutic adherence
Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken.

Full Information

First Posted
January 10, 2019
Last Updated
January 28, 2019
Sponsor
Kern Pharma, S.L.
Collaborators
Analysis and Research Network, S.L
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1. Study Identification

Unique Protocol Identification Number
NCT03820453
Brief Title
Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
Official Title
Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
August 29, 2019 (Anticipated)
Study Completion Date
August 29, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kern Pharma, S.L.
Collaborators
Analysis and Research Network, S.L

4. Oversight

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

5. Study Description

Brief Summary
This clinical Trial will assess the effects of a dietary supplement based on Tribulus terrestris on the libido and sexual function in postmenopausal women, by doing a follow up of the FSFI scale and different variables during 3 months period. Participants will be allocated to dietary supplement or placebo, and will attend to 3 visits (baseline, 6 weeks, 12 weeks and at 24 weeks optional).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Arousal Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Experimental
Arm Description
One tablet per day in the morning through oral administration of a dietary supplement containing Tribulus terrestris as the main active ingredient. During three months with the possibility to extend for another three months.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
One tablet per day in the morning through oral administration of Placebo. During three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tribulus Terrestris
Intervention Description
The experimental arm will receive a dietary supplement to increase the libido and sexual function
Intervention Type
Other
Intervention Name(s)
Placebo treatment
Intervention Description
The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics
Primary Outcome Measure Information:
Title
Changes of Score on the Female Sexual Function Index (FSFI)
Description
Score on the Female Sexual Function Index (FSFI) Questionnaire on female libido. The scale has 19 questions divided in 6 Domains. Total score ranges from 2 to 36 with higher scores considered better outcome. Scale subdomains, their scoring range and factor to the total score is the following: Domain: Desire, Range [1 - 5] Factor: 0.6 Domain: Arousal, Range [0 - 5] Factor: 0.3 Domain: Lubrication, Range 0 - 5 Factor: 0.3 Domain: Orgasm Range 0 - 5 Factor: 0.4 Domain: Satisfaction Range [0 (or 1) - 5 ] Factor: 0.4 Domain: Pain Range [0-5] Factor: 0.4
Time Frame
At baseline, at 6 weeks, at 3 months and at 6 months (optional)
Secondary Outcome Measure Information:
Title
Variations in testosterone levels (total, bioavailable, and free)
Description
Testosterone levels (total, bioavailable and free) in blood
Time Frame
Change from baseline to 3 months visit
Title
Change in quality of life (QoL) - Measured with Score on the Cervantes Scale.
Description
Score on the Cervantes Scale on quality of life. The scale is composed of 31 questions divided in 4 domains. Each question is punctuated from 0 to 5. And total scale result ranges from 0 to 155, where 0 corresponds to the maximun QoL value and 155 worst value.
Time Frame
Change from baseline, to 3 months and optional visit at 6 months
Title
Number of adverse events
Description
Number of adverse events (recorded in the investigator's CRF) to assess the tolerability/safety of the product
Time Frame
Thought the study, an average of 10 months.
Title
Compliance with treatment - Measured with the Morisky-Green scale
Description
The Morisky-Green scale measures treatment adherence with four yes or no questions. In which yes punctuates 0 and no punctuates 1. Possible result values for the scale goes from 0 to 4 with 4 being a better outcome than 0.
Time Frame
3 months
Title
Compliance with treatment - Recount of refounded product by patient.
Description
Recount of product returned at the end of study
Time Frame
3 months
Title
Compliance with treatment -Therapeutic adherence
Description
Data will be collected by the investigator at participants visit with a unique question about percentage of intake. It will be considered a good compliance if 80% of the medication has been taken.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who report decreased libido and present female sexual arousal disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria Post-menopause. Age between 45 and 65 years. Sexually active. Agreement to participate and to sign the informed consent documents. Exclusion Criteria: Pregnancy. Women who are on hormone replacement therapy or who need to start it. Cancer treatment or a recent history of cancer (<2 years). Any of the following treatments: serotonin inhibitors, GABAergics, tricyclics, antipsychotics, beta-blockers, thiazide diuretics, dopaminergics and anxiolytics for chronic problems (patients on treatment with anxiolytics without chronic problems are eligible) Fibromyalgia. Treatment for, or a history of, oestrogen-dependent cancer (breast, uterus, endometrium, etc.). Any comorbidity that may interfere with the pathology under study.
Facility Information:
Facility Name
CAP Manso
City
Barcelona
ZIP/Postal Code
08015
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Fundació Puigvert
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Clínic, Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Sexology Institute
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisca Molero
Phone
+34 934516598

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trial to Investigate the Effectiveness of a Dietary Supplement in Increasing Libido and Sexual Function in Postmenopausal Women.

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