Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer (NCT03180294) | Clinical Trial Compass
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 range18 Years
SexFEMALE
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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 …
What they're measuring
1
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)