Clinical trial · Interventional
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
NCT03704454CI-TRIAL-00035261unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Climacteric; Menorrhagia, Menopausal | — | UNRESOLVED | — |
| Menopause | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 100 mg PYC and then placebo | Dietary Supplement | — | UNRESOLVED |
| 50 mg PYC and then placebo | Dietary Supplement | — | UNRESOLVED |
| Placebo and then 100 mg PYC | Dietary Supplement | — | UNRESOLVED |
| Placebo and then 50 mg PYC | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A - PYC & Placebo
- description
- 50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
- interventionNames
- Dietary Supplement: 50 mg PYC and then placebo
- type
- EXPERIMENTAL
- label
- Group B - PYC & Placebo
- description
- 100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
- interventionNames
- Dietary Supplement: 100 mg PYC and then placebo
- type
- EXPERIMENTAL
- label
- Group C - Placebo & PYC
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patient currently is undergoing treatment for cancer * Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer * \> 18 years of age * Willing to travel to a Legacy Health facility if necessary * Agree to attend study visits outside of standard of care visits, if needed * Willing to stop other supplements or medications that are aimed at treating menopausal symptoms at least 7 days before beginning study treatment * Willing to engage in pre/post testing and survey/phone calls Exclusion Criteria: * Patient is currently undergoing chemotherapy treatment * \< 18 years of age * Unable to comply with protocol * Unable to provide written informed consent * Investigator does not believe study participation is in the best interest of the patient * Patient had concurrent menopausal symptoms prior to the start of cancer treatment * Menopausal symptoms are unrelated to surgical or medical treatment of breast or gynecologic cancers
References
Publications (0)
Data not yet available
No reference posted for this study.