Ejaculatory and Orgasmic Dysfunction Registry

Ejaculatory and Orgasmic Dysfunction Registry (Climax Registry)

The goal of this observational study is to evaluate the safety and efficacy of various therapies used to treat ejaculatory and/or orgasmic dysfunctions in men. The objective is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction.

Participants will submit questionnaires about their diagnosis and treatment efficacy and multiple time intervals.

Study Overview

• Status: Recruiting
• Conditions: Premature Ejaculation; Ejaculatory Dysfunction; Delayed Ejaculation; Anorgasmia; Anejaculation; Dysejaculation; Dysorgasmia

Detailed Description

The objective of the current study is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction. To accomplish this registry, CURE PD has partnered with the Sexual Medicine Society of North America (SMSNA) to help inform sexual medicine providers of the existence of the study and to help encourage patients to enroll.

Subjects meeting criteria will be offered study entry by their local provider who will refer them to an email address to indicate their interest. Participants will then be administered questionnaires at baseline and every 3 months x 1 year, followed by every 6 months x 2 years. Patient partners will also be allowed to enroll and will receive questionnaires on the same schedule (baseline, q3 months x 1 year, q6 months x 2 years).

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Utah
    • Orem, Utah, United States, 84057
      • Recruiting
      • The Male Fertility and Peyronie's Clinic
      • Sub-Investigator: Holli Burgon
      • Contact: Landon Trost, MD; Phone Number: 888-655-0015; Email: email@mfp.clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult men (>18) diagnosed with ejaculatory and/or orgasmic dysfunction who were recommended to begin any treatment for the condition

For partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment

Description

Inclusion Criteria:

• Men being treated for either ejaculatory and/or orgasmic dysfunction
• For partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	Report subjective efficacy of therapies used to treat ejaculatory dysfunction. Study participants will have the option of indicating if they had used any treatments to treat ejaculatory disorders. If so, they will then be asked to measure its efficacy at improving their symptoms using a 1-10 scale (10 being very effective).	3 years

Collaborators and Investigators

• Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: premature ejaculation; anorgasmia; ejaculatory dysfunction; delayed ejaculation; anejaculation; dysejaculation; dysorgasmia
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Ejaculatory Dysfunction; Premature Ejaculation
• Other Study ID Numbers: CUREPD200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data will be made available to sites which have referred patients to the registry.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No