NCT04052217

Brief Summary

Our hypothesis is that reducing the length of the penis does not lead to loss of sexual satisfaction or emotional closeness in the female partner. This will be investigated by a single case experimental design in 12 couples.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

August 7, 2019

Last Update Submit

August 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall Sexual Pleasure on a Visual Analogue Scale

    Overall Sexual Pleasure on a Visual Analogue Scale between 0-100

    Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks

Secondary Outcomes (2)

  • Sexual Pleasure from Intercourse on a Visual Analogue Scale

    Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks

  • Emotional Connection on a Visual Analogue Scale

    Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks

Study Arms (4)

Control Ring

OTHER

"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)

Device: Penile Ring

1" RIng

EXPERIMENTAL

Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)

Device: Penile Ring

1.5" Ring

EXPERIMENTAL

Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)

Device: Penile Ring

2" Ring

EXPERIMENTAL

Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)

Device: Penile Ring

Interventions

Penile Ring at base of penis

1" RIng1.5" Ring2" RingControl Ring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heterosexual couples in a stable relationship (defined as 6 months or more)
  • Having regular intercourse (defined as on average twice a week).

You may not qualify if:

  • Any current sexual dysfunction in either partner
  • Any current emotional disorder in either partner
  • Men with a micro-penis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Anxiety Disorders and Trauma

London, se5 8az, United Kingdom

Location

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Masking of female participant
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Single Case Experimental Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

March 1, 2017

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

All original data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
10 years

Locations