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Prednisone for Vasectomy Reversal Outcomes

Phase 4

Waitlist Available

Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-65 years of age

Men undergoing a first-time vasectomy reversal at the Male Fertility and Peyronie's Clinic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial looks at the effects of prednisone on sperm parameters and pregnancy rates after a vasectomy reversal. It also assesses any adverse effects of using prednisone.

Who is the study for?

This trial is for men aged 18-65 who want to restore fertility after a vasectomy, have previously fathered a child, and are undergoing their first vasectomy reversal. Their partner must be under 36 with no known fertility issues and not on birth control recently. Men can't join if they've had chemotherapy, testosterone use within the last year, kidney problems, diabetes, high blood pressure or only one testicle.Check my eligibility

What is being tested?

The study is looking at how prednisone affects sperm count and quality after a man has his vasectomy reversed. It also aims to see if prednisone changes the chances of getting pregnant post-reversal. The effects will be studied across different ways of using prednisone.See study design

What are the potential side effects?

Possible side effects from taking prednisone may include mood swings, increased appetite leading to weight gain, trouble sleeping (insomnia), slower wound healing or infection due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am a man planning my first vasectomy reversal at the Male Fertility and Peyronie's Clinic.

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My partner and I are trying to get pregnant now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess adverse events with prednisone utilization

Secondary outcome measures

Impact of Prednisone on semen concentration post vasectomy reversal

Impact of prednisone on pregnancy rates post vasectomy reversal.

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389

98%

Anemia

93%

Leukocytes decreased

90%

Lymphopenia

84%

Neutrophils decreased

78%

Neuropathy-sensory

75%

Alopecia

74%

Fatigue

67%

Nausea

60%

Hyperglycemia

52%

Constipation

46%

Hypoalbuminemia

40%

Myalgia

34%

Stomatitis

33%

Insomnia

32%

Vomiting

27%

Platelets decreased

26%

Alkaline phosphatase increased

26%

Aspartate aminotransferase increased

23%

Dyspnea

20%

Dyspepsia

19%

Dysphagia

19%

Headache

16%

Anorexia

16%

Arthralgia

15%

Neuropathy-motor

15%

Abdominal pain

14%

Infection w/o neutropenia

14%

Cough

14%

Fever

13%

Rash/desquamation

13%

Diarrhea w/o prior colostomy

12%

Bone pain

11%

Weight gain

11%

Taste disturbance

11%

Anxiety/agitation

10%

Sweating

10%

Radiation dermatitis

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Hypoglycemia

Dysphagia-esophageal radiation

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Prednisone Monthly - ScheduledExperimental Treatment1 Intervention

Group 2 will receive 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be given at the beginning of months 0, 2, and 4 and will be self-administered.

Group II: Prednisone Monthly - As NeededExperimental Treatment1 Intervention

Group 3 will receive a maximum of 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be administered based on sequential semen analyses. If a semen analysis demonstrates a drop in concentration from a prior analysis or if it shows a 0 concentration, the course will be administered.

Group III: Prednisone Every Other WeekExperimental Treatment1 Intervention

Group 4 will receive alternating 1 week dosages of prednisone (1 week on, 1 week off - 5 mg daily only) for a total of 24 weeks

Group IV: ControlActive Control1 Intervention

Group 1 will represent controls and will not receive prednisone in the 3-year post-op period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Charitable Union for the Research and Education of Peyronie's DiseaseLead Sponsor

3 Previous Clinical Trials

280 Total Patients Enrolled

Benjamin GreenStudy DirectorThe Male Fertility and Peyronie's Clinic

Media Library

Prednisone Clinical Trial Eligibility Overview. Trial Name: NCT04788823 — Phase 4

Prednisone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04788823 — Phase 4

Vasectomy Reversal Research Study Groups: Control, Prednisone Every Other Week, Prednisone Monthly - As Needed, Prednisone Monthly - Scheduled

Vasectomy Reversal Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT04788823 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What earlier researches have been conducted with respect to Prednisone?

"Currently, 334 clinical trials exploring Prednisone are underway with 92 in the final phase. The majority of these experiments occur at a single site in Duarte, California; however, 16404 locations have participated in researching this compound."

Answered by AI

Does this program currently have openings for participants?

"Clinicaltrials.gov reveals that this medical investigation is still seeking participants. It was initially posted on February 24th 2021 and had its most recent update nearly one year later, on July 19th 2022."

Answered by AI

What are the criteria for individuals to become part of this medical experiment?

"This clinical trial is welcoming up to 100 participants who have had a vasectomy reversal and are in the age range of 18-65."

Answered by AI

What is the capacity of this clinical trial in terms of participants?

"Affirmative. Clinicaltrials.gov reveals that this trial, initially posted on February 24th 2021, is still open to participants. 100 individuals will be recruited from 1 location for the experiment's duration."

Answered by AI

Is this research program actively seeking participants above the age of fifty?

"This research is seeking adult individuals between the age of majority and 65 years old."

Answered by AI

What potential side effects should patients be aware of before taking Prednisone?

"The safety of Prednisone has been validated through a Phase 4 trial, thus it is granted the highest score of 3."

Answered by AI

What conditions can Prednisone be employed to alleviate?

"Prednisone is regularly prescribed to treat thyroiditis, but it can also be used in conjunction with other treatments for malignant neoplasms, ulcerative colitis and varicella-zoster virus acute retinal necrosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Prednisone on Semen Parameters and Pregnancy Rates Post Vasectomy Reversal

2021. "The Impact of Prednisone on Semen Parameters and Pregnancy Rates Post Vasectomy Reversal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04788823.

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