CLINICAL TRIALS PROFILE FOR ESTROGENS, ESTERIFIED
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All Clinical Trials for estrogens, esterified
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00141544 ↗ | The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women | Terminated | Solvay Pharmaceuticals | Phase 2 | 2004-07-01 | To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets |
| NCT00141557 ↗ | The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women | Terminated | Solvay Pharmaceuticals | Phase 2 | 2004-07-01 | To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets |
| NCT00141570 ↗ | Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women | Completed | Solvay Pharmaceuticals | Phase 2 | 2004-06-01 | To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets |
| NCT00160342 ↗ | Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes | Completed | Solvay Pharmaceuticals | Phase 2 | 2005-06-01 | This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women |
| NCT00357006 ↗ | A Definitive Estrogen Patch Study (ADEPT) | Completed | Stanley Medical Research Institute | Phase 2 | 2006-07-01 | OBJECTIVE: To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia. HYPOTHESIS: That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo. STUDY POPULATION: 180 women will be recruited over a three-year period across three sites. Participant will be of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)according to the Mini International Neuropsychiatric Interview (MINI). STUDY MEDICATION: Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive 100mcg Estradiol; one third of the participants (n=60) will be randomised to receive adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be randomised to receive adjunctive placebo n=60). All patches will be covered with identical adhesive contact to ensure the "blind" is maintained. STUDY EVALUATIONS: Data will be collected over a two-month period for each participant. Visits will be performed at baseline, and then at weekly or fortnightly intervals. A total of six visits will be completed for each participant. The following evaluations will be performed: i) Inclusion/exclusion checklist. (Baseline visit only) ii) Informed consent. (Baseline visit only) iii)psychiatric evaluation to determine diagnosis. (Baseline visit only) iv) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits) v) Medication history. (Baseline and evaluation visits) vi) Demographics. (Baseline visits only) vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS), which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure changes in subject's reported side effects during the trial. viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen, Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits). |
| NCT00357006 ↗ | A Definitive Estrogen Patch Study (ADEPT) | Completed | The Alfred | Phase 2 | 2006-07-01 | OBJECTIVE: To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia. HYPOTHESIS: That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo. STUDY POPULATION: 180 women will be recruited over a three-year period across three sites. Participant will be of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)according to the Mini International Neuropsychiatric Interview (MINI). STUDY MEDICATION: Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive 100mcg Estradiol; one third of the participants (n=60) will be randomised to receive adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be randomised to receive adjunctive placebo n=60). All patches will be covered with identical adhesive contact to ensure the "blind" is maintained. STUDY EVALUATIONS: Data will be collected over a two-month period for each participant. Visits will be performed at baseline, and then at weekly or fortnightly intervals. A total of six visits will be completed for each participant. The following evaluations will be performed: i) Inclusion/exclusion checklist. (Baseline visit only) ii) Informed consent. (Baseline visit only) iii)psychiatric evaluation to determine diagnosis. (Baseline visit only) iv) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits) v) Medication history. (Baseline and evaluation visits) vi) Demographics. (Baseline visits only) vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS), which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure changes in subject's reported side effects during the trial. viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen, Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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