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Progestin Androgenic Activity

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461. Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition

); hemodynamically important valvular disease; secondary hypercholesterolemia; gastrointestinal disease that might limit drug absorption or partial ileal bypass; myopathy, or rhabdomyolysis; a known hypersensitivity to statins; using any androgenic, estrogenic, progestogenic, antiandrogenic, or antiestrogenic agents or medications that can alter the gonadal steroid milieu; using systemic immunosuppressants or anticoagulants; plasma creatine kinase levels >50% above the upper limit of normal,transient ischaemic (...) type 2 diabetes mellitus over the age of 40 years without overt CVD,but with one or more major cardiovascular risk factors Exclusion Criteria: uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >95 mm Hg); evidence of active active liver disease or hepatic dysfunction defined as a level of liver transaminases >2 times the upper limit of normal; uncontrolled myocardial ischaemia; congestive heart failure (New York Heart Association classification IIIb or IV

2007 Clinical Trials

462. A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol

elevated LDL cholesterol Exclusion Criteria: current pregnancy or breastfeeding current use of oral contraceptives, progestins insulin sensitizing medications thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its (...) of PCOS with elevated LDL cholesterol. Condition or disease Intervention/treatment Phase Polycystic Ovary Syndrome Drug: Lipitor Drug: Placebo Phase 2 Detailed Description: The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo. Study Design Go to Layout table for study information Study Type

2007 Clinical Trials

463. Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)

Sharp & Dohme Corp. Study Details Study Description Go to Brief Summary: Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women. Tibolone could be more acceptable for long-term use, in particular since it does not induce a regular withdrawal bleed. The objective of this trial is to compare placebo and tibolone, a steroid with tissue specific activity, in the prevention of spinal fractures in women (...) : A Multinational, Multicenter, Randomized, Double-Blind, Parallel Group,Placebo Controlled Clinical Trial of the Effects of Tibolone (Org OD-14 1.25mg) on the Incidence of New Vertebral Fractures in Osteoporotic Postmenopausal Women. Study Start Date : July 2001 Actual Primary Completion Date : August 2006 Actual Study Completion Date : August 2006 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: 1 Tibolone

2007 Clinical Trials

464. PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue

T concentrations compared to T alone. The investigators will test the hypothesis that the addition of a 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T, by reducing intraprostatic DHT, will decrease prostate epithelial proliferation, assessed by Ki-67 labeling index (Ki-67LI), and increase apoptosis, assessed by caspase-3 expression, and decrease androgen-regulated protein expression such as prostate specific antigen (PSA). The investigators will test the hypothesis (...) that the addition of a 5α-reductase inhibitor or the progestin IM DMPA to exogenous T, by modifying the intraprostatic hormonal milieu, will alter prostate epithelial gene expression. Specifically, the investigators expect that the addition of the 5α-reductase inhibitor dutasteride or the progestin IM DMPA to exogenous T, will result in decreased expression of androgen-regulated genes such as PSA. Condition or disease Intervention/treatment Phase Healthy Drug: Testosterone gel Drug: Dutasteride Drug: Depo

2007 Clinical Trials

465. The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels

Actual Primary Completion Date : March 2007 Actual Study Completion Date : March 2007 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Red Wine Other: Red Wine 8 ounces of assigned beverage (red wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins. Active Comparator: White Wine Other: White Wine 8 ounces of assigned beverage (white wine) each evening (...) not currently, or within the past 3 months, using oral contraceptives or other hormone replacement therapy Exclusion Criteria: male irregular menstrual cycles or vasomotor symptoms within the last 12 months pregnant (or breast feeding) any hormone therapy including phytoestrogens, oral contraceptives, SERMs (selective estrogen receptor modulators), or androgens (or precursors) for three months prior to the study history of alcohol abuse history of any estrogen-dependent neoplasia high intake of dietary soy

2007 Clinical Trials

466. Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

starting after 54 years of age. A history or active presence of clinically important medical diseases. Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov

2006 Clinical Trials

467. Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

T4-L4)). Exclusion Criteria: Subjects with any of the following criteria were not considered for enrollment into the study : ·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication. Contacts and Locations Go to Information from the National Library (...) : 1231 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months. Study Start Date : July 2004 Actual Primary Completion Date : March 2007

2006 Clinical Trials

468. Bioidentical 'Natural' Hormone Evaluation in Early Menopause

more recently than 3 months: Estrogen Calcitonin Corticosteroids Progestins Progesterone Lithium Androgen Heparin Herbal menopause treatments SERMS Fluorides Phosphate binding antacids Bisphosphonates Vitamin D 50,000IU Anticonvulsants Patients who received any investigational drug within the proceeding month Tobacco use will not be allowed Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research (...) of Bioidentical Hormones Study Start Date : February 2006 Actual Primary Completion Date : January 2014 Actual Study Completion Date : September 2014 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: 1 equine estrogens m-progesteroneacetate Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed

2006 Clinical Trials

469. Livial Intervention Following Breast Cancer; Efficacy, Recurrence and Tolerability Endpoints (LIBERATE)(COMPLETED)(P05885)

. Tibolone is a steroid with estrogenic, progestogenic and androgenic activity and is registered for treatment of climacteric complaints. Tibolone has a pharmacologic and clinical profile that is different from conventional hormones. In contrast to conventional hormones, tibolone does not increase breast density and causes less breast pain. The LIBERATE study is a study in which the safety and efficacy of tibolone has been investigated in postmenopausal women that have been treated for breast cancer (...) for vasomotor symptoms within 4 weeks prior to baseline. Use of progestogen implants or injections and/or estrogen/progestogen injectable therapy within the past 6 months. Use of estrogen implants or injections within the past 5 years. Use of raloxifene hydrochloride and/or any non-registered investigational drug within the last 8 weeks. Active deep vein thrombosis, thromboembolic disorders, or a documented history of these conditions. Severe liver disorders. Abnormal laboratory values considered

2006 Clinical Trials

470. Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women

diagnosis of MDD, single or recurrent episode, without psychotic features using the modified MINI International Neuropsychiatric Interview (MINI). Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the screening and baseline visit. Exclusion Criteria: Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator (SERM)-containing drug products 8 weeks before baseline. Current (within 12 months) psychoactive substance abuse or dependence (including alcohol (...) for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: A Drug: Desvenlafaxine succinate sustained-release (DVS SR) flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months. Active Comparator: B Drug: Escitalopram Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months. Outcome Measures Go to Primary Outcome Measures : Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline

2006 Clinical Trials

471. Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes

our for details. ClinicalTrials.gov Identifier: NCT00433589 Recruitment Status : Active, not recruiting First Posted : February 12, 2007 Last Update Posted : September 8, 2017 Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Collaborators: Agendia Breast International Group Roche Pharma AG Novartis Sanofi Information provided by (Responsible Party): European Organisation for Research and Treatment of Cancer - EORTC Study Details Study Description Go to Brief Summary (...) ): A Prospective, Randomized Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemotherapy in Breast Cancer With 0 to 3 Positive Nodes Study Start Date : December 2006 Estimated Primary Completion Date : March 2020 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Arm I (anthracycline-based) FEC 100 Canadian

2007 Clinical Trials

472. Comparison of Tibolone and Raloxifene on Bone Mineral Density in Osteopenic Postmenopausal Women (P06090)

topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 tibolone Drug: tibolone 2 years treatment with tibolone (1.25 mg Org OD-14) Active Comparator: 2 raloxifene Drug: raloxifen 2 years treatment with raloxifene (60 mg) Outcome Measures Go to Primary Outcome Measures : Measure BMD to evaluate the effects of treatment on bone mineral density of the lumbar vertebrae L1-L4 [ Time Frame: At screening, after 52 weeks and 104 weeks ] Secondary Outcome Measures (...) . If treatment duration was less than 6 months a wash-out period of 12 months is necessary. Treatment with etidronate for 1 year a wash-out period of 6 months is necessary. If treatment period of more than 1 year a wash -out period of 12 months is necessary. Treatment with oral estrogen and/or progestin therapy (including contraceptives) or transdermal therapy and local estrogen applications within 6 months prior to screening/baseline BMD measurements (i.e. the wash -out period of 6 months must have been

2007 Clinical Trials

473. Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)

, orally, once a day (preferably at the same time). Other Name: Activelle® Active Comparator: 2 low-dose estradiol/noresterone Drug: tibolone uncoded tablets, at a dose of 2.5 mg per tablet; Subjects were to take 1 Livialâ tablet and 1 -matched Activelleâ placebo tablet, orally, once a day (preferably at the same time). Other Name: Livial Outcome Measures Go to Primary Outcome Measures : For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal (...) women, >= 45 and < 65 years of age, with an intact uterus. Subjects must have been postmenopausal for less than 15 years. Body Mass Index >18 and =< 32 kg/m2. Voluntary written informed consent is required. Exclusion Criteria: Any unexplained abnormal uterine bleeding after the menopause. Double layer endometrial thickness = 6 mm as assessed by transvaginal ultrasonography. Treatment with oral estrogen and/or progestogen therapy within 4 weeks prior to screening, or treatment with transdermal

2007 Clinical Trials

474. Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

17 beta-cypionate Methyltestosterone Desogestrel Etonogestrel Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Contraceptives, Oral, Synthetic Contraceptives, Oral Progestins (...) Primary Completion Date : December 2006 Actual Study Completion Date : December 2006 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Arm 1 etonogestrel with testosterone undecanoate Drug: etonogestrel with testosterone undecanoate 42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks Placebo Comparator: Arm 2 Placebo Drug: Placebo 42

2006 Clinical Trials

475. Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

at screening: Moderate hot flush: warm sensation with sweating, does not disrupt activity. Severe hot flush: hot sensation with sweating, disrupts activity. Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI. Exclusion Criteria: Hypersensitivity to venlafaxine (Effexor or Effexor XR). Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior (...) to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening. History of a seizure disorder other than a single childhood febrile seizure. Contacts and Locations Go to Information from the National Library of Medicine To learn more

2007 Clinical Trials

476. DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

Detailed Description: Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance (...) of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity, Women having a low maturation index and a vaginal pH above 5, Endometrial thickness of 4 mm or less at transvaginal ultrasonography, Body weight within 18.5 and 32.0 according to body mass index. Exclusion Criteria: Undiagnosed abnormal genital bleeding, Active or history of thromboembolic disease, Significant metabolic

2007 Clinical Trials

477. Effect of Race on Gonadotropin Responses

to Short Term Negative and Positive Feedback Effects of Gonadal Steroids Study Start Date : January 2005 Actual Primary Completion Date : December 2011 Actual Study Completion Date : December 2011 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: African American women 18-35 yo intervention: estradiol steroid infusion and progesterone steroid infusion Drug: Estradiol steroid infusion (...) Estradiol infusion of 0.1 mcg/kg/hr for 12 hr, 0.135 mcg/kg/hr for 12 hr, 0.165 mcg/kg/hr for 12 hr and 0.2 mcg/kg/hr for 60 hr Other Name: E2 Drug: Progesterone steroid infusion Progesterone infusion of 4.77 nmol/kg/hr (1.5 mcg/kg/hr) for 24 hr and 6.36 nmol/kg/hr (2 mcg/kg/hr) for the final 24 hr Other Name: P Active Comparator: Caucasian women 18-35 yo intervention: estradiol steroid infusion intervention: progesterone steroid infusion Drug: Estradiol steroid infusion Estradiol infusion of 0.1 mcg/kg

2007 Clinical Trials

478. Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)

-uterine progestogen Unsuccessful previous treatment with androgens or compounds known to enhance androgenic activity Current successful treatment with androgens, without applying the applicable washout period of 3 months prior to screening Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (previous low dose vaginal estrogen-only applications are allowed) Use of anti -androgens within the preceding 5 years prior to screening. Women (...) months duration prior to screening. Women were to be sexually active. Normal mammography within 6 months prior to randomization. Body mass index >18 and <=32 kg/m2. Voluntary written informed consent Exclusion Criteria: Any unexplained abnormal uterine bleeding Double layer endometrial thickness >4 mm Tibolone or transdermal E2/NETA use within 3 months prior to screening Progestogen implants or injections and estrogen/progestogen injectable therapy within 6 months prior to screening Use of intra

2006 Clinical Trials

479. Effects of Hormonal Contraceptives on Liver Proteins and Coagulation Factors: A Comparison of a Contraceptive Vaginal Ring and an Oral Contraceptive

and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol. Condition or disease Intervention/treatment Phase Contraception Drug: Nestorone/ethinyl estradiol contraceptive vaginal ring; levonorgestrel/ethinyl estradiol oral contraceptive Phase 2 Detailed Description (...) : The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol. Study Design Go to Layout table for study information

2005 Clinical Trials

480. Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

Criteria: Generally healthy, postmenopausal women, aged 40 to less than 65 years Intact uterus At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL. Exclusion Criteria: Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy) A history or active presence of clinically important medical disease Malabsorption disorders (...) Other: Placebo Phase 3 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 1083 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention Official Title: A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention

2005 Clinical Trials

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