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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR DANAZOL

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Clinical Trials for Danazol

Trial ID Title Status Sponsor Phase Summary
NCT00003946 Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer. PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.
NCT00003946 Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer Completed Gynecologic Oncology Group Phase 2 RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer. PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with advanced or recurrent endometrial cancer.
NCT00206544 Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women? Completed National Health and Medical Research Council, Australia Phase 2 OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: - Psychiatric evaluation to determine diagnosis. (Baseline visit only) - General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) - Medication history (baseline and evaluation visits). - Demographics (baseline visits only). - Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. - Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). - Inclusion/exclusion checklist (baseline visit only). - Informed consent (baseline visit only).
NCT00206544 Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women? Completed Stanley Medical Research Institute Phase 2 OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: - Psychiatric evaluation to determine diagnosis. (Baseline visit only) - General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) - Medication history (baseline and evaluation visits). - Demographics (baseline visits only). - Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. - Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). - Inclusion/exclusion checklist (baseline visit only). - Informed consent (baseline visit only).
NCT00206544 Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women? Completed The Alfred Phase 2 OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: - Psychiatric evaluation to determine diagnosis. (Baseline visit only) - General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) - Medication history (baseline and evaluation visits). - Demographics (baseline visits only). - Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. - Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). - Inclusion/exclusion checklist (baseline visit only). - Informed consent (baseline visit only).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Danazol

Condition Name

Condition Name for Danazol
Intervention Trials
Endometriosis 5
Diabetic Macular Edema 2
Adenomyosis 2
Infertility 2
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Condition MeSH

Condition MeSH for Danazol
Intervention Trials
Endometriosis 5
Infertility 3
Purpura 2
Anemia 2
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Clinical Trial Locations for Danazol

Trials by Country

Trials by Country for Danazol
Location Trials
United States 62
Japan 2
Egypt 2
France 1
Brazil 1
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Trials by US State

Trials by US State for Danazol
Location Trials
New York 4
Massachusetts 3
Maryland 3
Colorado 3
Arizona 3
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Clinical Trial Progress for Danazol

Clinical Trial Phase

Clinical Trial Phase for Danazol
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Danazol
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 6
Recruiting 3
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Clinical Trial Sponsors for Danazol

Sponsor Name

Sponsor Name for Danazol
Sponsor Trials
Assistance Publique - Hôpitaux de Paris 2
National Heart, Lung, and Blood Institute (NHLBI) 2
Mayo Clinic 2
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Sponsor Type

Sponsor Type for Danazol
Sponsor Trials
Other 26
Industry 4
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
Mallinckrodt
UBS
Harvard Business School
Johnson and Johnson
Argus Health
Citi
Cerilliant

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