Clinical trial · Interventional
Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer
A Phase II Trial of Two Doses of Conjugated Estrogens (Premarin) in Patients With Androgen-Independent Prostate Cancer
NCT00134654CI-TRIAL-00005029completedPhase 2ClinicalTrials.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)
The purpose of this study is to see if Premarin is useful against androgen-independent prostate cancer and to help understand how drugs such as Premarin may work.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Premarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Premarin once a day
- interventionNames
- Drug: Premarin
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Premarin 3 times a day
- interventionNames
- Drug: Premarin
Primary outcomes (1)
- measure
- To evaluate the efficacy of two different doses of Premarin in the treatment of patients with androgen-independent prostate cancer
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented histologic evidence of prostate cancer. * Progressive androgen-independent prostate cancer as defined by the Prostate-Specific Antigen (PSA) Working Group after conventional androgen deprivation and antiandrogen withdrawal. * PSA \> 2ng/ml and serum testosterone of \< 50ng/ml * No history of thromboembolic disease within the prior year * ECOG performance status of 0-2 * Creatinine \< 2 x upper limit of normal * Bilirubin \< 2 x upper limit of normal * AST \< 2 x upper limit of normal Exclusion Criteria: * Unstable angina or change in anginal symptoms within the past 6 months. * Prior therapy with estrogens or PC-SPECS. * Concurrent megestrol acetate or steroid hormones * Major surgery or radiation therapy within 4 weeks * Strontium-89 or samarium-153 therapy within 8 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.