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NCT03180294 Clinical Trial

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

Breast Carcinoma Clinical Trial

Official title:
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03180294
Other study ID # NRG-CC004
Secondary ID NCI-2017-00344NR
Status Completed
Phase Phase 2
First received
Last updated
Start date May 31, 2017
Est. completion date February 22, 2021

Study information
Verified date February 2022
Source NRG Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.

Description:

PRIMARY OBJECTIVES: I. Measure the ability of two dose levels of bupropion hydrochloride (bupropion), 150 or 300 mg of extended release, to improve sexual desire more than a placebo at 9 weeks (8 weeks on the target dose) as measured by the desire subscale of the female sexual function index (FSFI). SECONDARY OBJECTIVES: I. Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm. II. Evaluate the effect of 150 and 300 mg of bupropion extended release on the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale, PROMIS sexual desire and satisfaction measure, patient health questionnaire (PHQ)-4, and the FSFI total score, at 5 and 9 weeks, as well as the desire subscale score of the FSFI at 5 weeks. III. Evaluate the effect of 150 and 300 mg of bupropion extended release on the global impression of change scale and the patient's perception of risk versus (vs.) benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose). Patients are randomized to 1 of 3 arms.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bupropion 150 mg XL
By mouth
• Placebo
By mouth
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Sponsors (2)
Lead Sponsor Collaborator
NRG Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire") The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol. Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue. Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire") The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol. Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction") The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol. Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Change From Baseline in FSFI Total Score ("Sexual Functioning") The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as "sexual functioning" in the protocol. Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
Secondary Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood") The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol. Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
Secondary Global Impression of Change at 9 Weeks ("Perception of Change") Participants are asked, "Since beginning the study agent, my desire of sexual intimacy is:" with seven possible answers of "very much better," "moderately better," "a little better," "about the same," "a little worse," "moderately worse," and "very much worse." The first three answers have been categorized as "Better' and the last three answers as "Not Better". This measure is referred to as "perception of change" in the protocol. 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Perception of Risk vs. Benefit at 9 Weeks Participants are asked, "Were the benefits of this treatment greater than any side effects?" 9 weeks from start of study treatment (within 21 days of randomization)
Secondary Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data. Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).
Secondary Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much). 9 weeks from start of study treatment (within 21 days of randomization).
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