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Completed INTERVENTIONAL NCT03180294

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

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

Sponsor: NRG Oncology

Updated 22 times since 2017 Last updated: Apr 7, 2026 Started: May 31, 2017 Primary completion: Feb 22, 2021 Completion: Feb 22, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Breast Carcinoma and Cervical Carcinoma and is currently completed. NRG Oncology leads this study, which shows 22 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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.

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.

Status Flow

~Jun 2017 – ~May 2018 · 11 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Jul 2019 · 4 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Mar 2020 · 5 months · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Nov 2020 · 3 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Apr 2022 · 10 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Apr 2026 · 8 months · monthly snapshotApr 28, 2026 – present · 52 days · daily API

Change History

22 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Completed

    Phase: PHASE2None

  2. Sep 2025 — Apr 2026 [monthly]

    Completed PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE2

Show 17 earlier versions
  1. Jun 2021 — Apr 2022 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Apr 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  5. Aug 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE2

  6. May 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  7. Mar 2020 — May 2020 [monthly]

    Recruiting PHASE2

  8. Oct 2019 — Mar 2020 [monthly]

    Recruiting PHASE2

  9. Aug 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  10. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE2

  11. Mar 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  12. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE2

  13. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE2

  14. Sep 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  15. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE2

  16. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

  17. Jun 2017 — May 2018 [monthly]

    Recruiting PHASE2

    First recorded

May 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • NRG Oncology
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .