CompletedPhase 2

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

United States230 participantsStarted 2017-05-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION * Score of \< 9 on the PHQ-4 * Patients must have a FSFI desire subscale baseline score less than 3.3 * NOTE-Both the PHQ-4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility * Diagnosis of breast or gynecologic cancer \[examples are lobular carcinoma in situ (LCIS),ductal carcinoma in situ (DCIS), invasive breast, ovarian, endometrial, vulvar, cervical and vaginal\] * Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy) * Post menopausal as defined by at least ONE of the following: * 12 months (365 days) without a period; * Bilateral oophorectomy; * Chemically induced menopause as long as there are no plans to stop during the study; * For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (\> 30 mIU/mL) and estradiol in menopausal range per institution?s laboratory (\< 10 for ultra sensitive assay: \< 25-30 otherwise); * At least one ovary intact and 180 days without a period with FSH (\> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (\< 10 for ultra sensitive assay: \< 25-30 otherwise); Note: Women 58 and older do not have to have hormonal tests. * History, physical and performance status of 2 or less within 180 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")

Timeframe: Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

Trial details

NCT IDNCT03180294

SponsorNRG Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-22

Results submitted2022-02-10

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