Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled

Impact of Escitalopram on Sperm DNA Fragmentation



Sponsors


Source

Weill Medical College of Cornell University

Oversight Info

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No

Is Us Export

Yes


Brief Summary

Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy
men with normal semen analyses and no psychiatric history of depression, bipolar, mania or
suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual
function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after
discontinuation of therapy (10 weeks into study).

Detailed Description

SSRI medications, specifically escitalopram is a very commonly prescribed medication among
men of reproductive age. Significant evidence exists that they may be harmful for paternal
fertility potential in both animal and human studies. However, high quality data is lacking,
particularly among commonly used SSRI's such as escitalopram. As such, it is important to
properly evaluate the potential effect of escitalopram in a randomized placebo controlled
fashion. Results will be important in guiding urologists, psychiatrists and family
practitioners regarding discussion surrounding SSRI use in their patients interested in
fertility.

Overall Status

Recruiting

Start Date

2017-10-01

Completion Date

2019-12-31

Primary Completion Date

2019-07-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks
6 weeks

Secondary Outcome

Measure

Time Frame

Absolute change in sperm DNA fragmentation from baseline to 6 and 10 weeks
0, 6, 10 weeks
Changes in sperm motility from baseline to 6 and 10 weeks
0, 6, 10 weeks
Changes in progressive motility from baseline to 6 and 10 weeks
0, 6, 10 weeks
Changes in viability from baseline to 6 and 10 weeks
0, 6, 10 weeks
Changes in concentration from baseline to 6 and 10 weeks
0, 6, 10 weeks

Enrollment

45

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

10mg by mouth daily for 6 weeks

Arm Group Label

Escitalopram


Intervention Type

Other

Intervention Name


Description

matched placebo control by mouth for 6 weeks

Arm Group Label

Placebo



Eligibility

Criteria

Inclusion Criteria:

- Normal semen analyses, or semen analyses with at least 5 million sperm

- Normal TUNEL value (<7%)

- Willing to engage in at least weekly sexual activity, with a partner or alone for the
duration of the 10-week study

Exclusion Criteria:

- Azoospermia or severe oligospermia (<5million sperm per semen analysis)

- Presently attempting to conceive pregnancy

- Sexual dysfunction preventing ability to provide semen analysis throughout study or
engage in weekly sexual activity

- Current psychiatric disorder including: bipolar, mania, depression, generalized
anxiety, social phobia, panic attacks, obsessive compulsive disorder, and
schizophrenia.

- Family history of bipolar disorder, or suicide (including 2nd degree relatives)

- Present use of psychotropic agents (prescription or herbal) or anticonvulsants

- Use of sleeping pills

- Alcohol consumption greater that 2oz/day

- Use of illicit drugs

- Inability to read, follow instructions or complete questionnaires in English.

- Use of hormonal medications in past 3 months (androgens, androgen blockade, anabolic
steroids, estrogens, herbal)

- Use of medications to enhance sexual function

- History of chemotherapy or pelvic radiation

- Use of Monoamine Oxidase inhibitors (MAOi's) or tricyclic antidepressants (TCAs)
within 14 days

- Liver disease

Gender

Male

Gender Based

Yes

Minimum Age

18 Years

Maximum Age

65 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Ryan Flannigan, MD
Principal Investigator
Weill Cornell Medicine
Peter Schlegel, MD
Principal Investigator
Weill Cornell Medicine
Phil Bach, MD
Principal Investigator
Weill Cornell Medicine

Overall Contact

Last Name

Adaobi Onunkwo

Phone

646-962-0534

Email



Location

Facility

Status

Contact

Investigator

Weill Cornell Medicine
New York New York 10065 United States
Recruiting
Last Name: Julie Carter
Last Name: Ryan Flannigan, MD
Role: Principal Investigator

Last Name: Marc Goldstein, MD
Role: Sub-Investigator

Last Name: James Kashanian, MD
Role: Sub-Investigator

Last Name: Peter Schlegel, MD
Role: Sub-Investigator

Last Name: Darius Paduch, MD
Role: Sub-Investigator


Location Countries

Country

United States


Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Citalopram

Dexetimide



Arm Group

Arm Group Label

Escitalopram

Arm Group Type

Experimental

Description

10mg by mouth daily for 6 weeks


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator

Description

Matched placebo control by mouth for 6 weeks.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Julie Carter

Phone

(212) 746-5706

Email



Other Outcome

Measure

Change in serum testosterone (ng/dL) from baseline to 6 and 10 weeks

Time Frame

0, 6, 10 weeks

Description

Serum testosterone measurement


Measure

Change in serum luteinizing hormone (LH) (mIU/mL) from baseline to 6 and 10 weeks

Time Frame

0, 6, 10 weeks

Description

Serum Luteinizing hormone measurement


Measure

Change in serum follicle-stimulating hormone (FSH) (mIU/mL) from baseline to 6 and 10 weeks

Time Frame

0, 6, 10 weeks

Description

Serum follicle-stimulating hormone measurement


Measure

Change in serum prolactin (ng/mL) from baseline to 6 and 10 weeks

Time Frame

0, 6, 10 weeks

Description

serum prolactin measurement


Measure

Change in International Index of Erectile Function Survey from baseline to 6 and 10 weeks

Time Frame

0, 6, 10 weeks

Description

International Index of Erectile Function Survey



Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Double (Participant, Investigator)


Study First Submitted

January 19, 2018

Study First Submitted Qc

May 15, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 15, 2018

Last Update Submitted Qc

May 15, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on August 23, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP