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Progestin Androgenic Activity

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181. Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

to participate in the study: have a history of invasive breast cancer or ductal carcinoma in situ, melanoma or any gynecologic cancer. using any of the following: oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening (visit 1) transdermal hormone products within 4 weeks before screening (visit 1) vaginal hormone products (rings, creams, gels) within 4 weeks before screening (visit 1) progestin implants/injectables, IUDs (...) to continue activity Severe: sensation of heat with sweating, causing cessation of activity. Secondary Outcome Measures : Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes [ Time Frame: Baseline and 4 weeks ] Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency. Change From Baseline to Week 4

2016 Clinical Trials

182. Hirsutism

are normal) occurs in about 23% of women. In these women, hirsutism is thought to be due to increased skin sensitivity to androgens. This may, in part, be caused by increased alpha-reductase activity enhancing the local conversion of testosterone to the more potent dihydrotestosterone. Less commonly, hirsutism may be caused by: Congenital adrenal hyperplasia. Androgen-secreting tumour (ovarian or adrenal). Cushing's syndrome. Acromegaly. Drugs (for example anabolic steroids, danazol, metoclopramide (...) of Hirsutism in Premenopausal Women [ ], which states that: COCs decrease plasma testosterone by suppression of luteinizing hormone secretion (thereby reducing ovarian androgen secretion) and by increasing the production of sex hormone-binding globulin (thereby increasing androgen binding and reducing free androgen levels). Cyproterone acetate (the progestogen component of Dianette ® ) has anti-androgenic properties and has been shown to be effective in managing hirsutism. Drospirenone also has anti

2014 NICE Clinical Knowledge Summaries

183. Endometriosis

gonadotrophins. They have androgenic, anti-oestrogenic, and anti-progestogenic activity, and usually cause amenorrhoea and induce a reversible menopausal state. Their use is limited by severe androgenic adverse effects which often outweigh the benefits. See prescribing information on for more information. Add-back hormone replacement therapy (HRT) should be initiated in secondary care for women taking GnRH analogues, or following hysterectomy and/or bilateral salpingo-oophorectomy surgery for endometriosis (...) Reproduction and Embryology (ESHRE) guideline Management of women with endometriosis [ ]. Progestogen-only pill (Cerazette ® ) — CKS found no studies assessing the effectiveness of Cerazette ® for endometriosis, and the recommendation to offer it is a pragmatic approach as a Cochrane review found no overall of benefit of oral progestagens over other medical treatments [ ]. Depot medroxyprogesterone acetate (Depo-Provera ® or SAYANA PRESS ® ) — this recommendation is based on expert opinion from CKS

2014 NICE Clinical Knowledge Summaries

184. Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia

, chronic renal failure or drugs which can increase LDL-C level (e.g. retinoids, cyclosporine A and phenothiazines) or decrease HDL-C level (e.g. progestins, androgens, β-blockers, probucol and anabolic steroid) Patients with lifestyle that may interfere treatment efficacy, such as alcoholism or drinking habits more than 3 times per week, late dinner, late night supper, frequent oversea business traveler, frequent social gathering, and patients who cannot anticipate a diet control and lifestyle changes (...) . Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02719028 Recruitment Status : Active, not recruiting First Posted : March 25, 2016 Last Update Posted : January 29, 2019 Sponsor: Golden Biotechnology Corporation

2016 Clinical Trials

185. Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

Recruitment Status : Active, not recruiting First Posted : April 18, 2016 Last Update Posted : May 30, 2018 Sponsor: Shire Information provided by (Responsible Party): Shire Study Details Study Description Go to Brief Summary: This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in preventing acute angioedema attacks in participants with Type I and Type II HAE. Condition or disease Intervention/treatment Phase Hereditary Angioedema (HAE) Drug: DX-2930 Phase 3 Study Design (...) and able to read, understand and sign an assent form. Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as Females (NOTE: Female rollover participants (those who previously participated in Study DX-2930-03 [NCT02586805]) of childbearing potential may continue to use the birth control method used during Study DX-2930-03 (NCT02586805).) of childbearing potential must agree to be abstinent or it is recommended to use highly

2016 Clinical Trials

186. Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducer, etc.) or stopped less than 3 months before the randomization (antihypertensive stable long-term treatment tolerated), Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, containing beta glucanes, konjac extract (...) by maltodextrin. Dietary Supplement: Placebo After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner. Experimental: VAL070-A Studied active product n°1, named VAL070-A, is a dietary supplement in shape of capsule. VAL070-A product contains 4 active plant extracts. Dietary Supplement: VAL070-A After

2016 Clinical Trials

187. Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder

or other anion exchange resins; Use of levothyroxine or other thyromimetics; Hypertriglyceridemia (triglycerides > 3 times the upper limit of normal (ULN)); Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (γ - GT), aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 times the ULN as measured at baseline); Severe kidney failure (eGFR <30 ml/min as measured at baseline); Use of any form of estrogen, progestin or androgen (...) estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study will test the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia. 154 patients with a schizophrenia spectrum disorder will be recruited in a multicenter twelve-week, randomized, double-blind, placebo-controlled

2016 Clinical Trials

188. Efficacy Study of Progesterone Tablet in Post-menopausal Women

products (soy, black cohosh, dong quai) during the past 3 months before the screening visit Use of any estrogen, progestin or androgen pellet or injectable therapy during the past 6 months before the screening visit Contraindications to hormone therapy: Active liver dysfunction or disease or history of severe liver disease Known, suspected or past history of hepatic tumors (benign or malign) Active or past history of arterial thromboembolic disease (e.g. angina, myocardial infarction, stroke, coronary (...) no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination, as determined by the medical investigator Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject Exclusion Criteria: Use of any estrogen, progestin, or estrogen/progestin drug products, androgens, selective estrogen receptor modulators (SERMs), phytoestrogen supplements or natural

2016 Clinical Trials

189. MLE4901 vs. Placebo for the Treatment of PCOS

by (Responsible Party): Millendo Therapeutics, Inc. Study Details Study Description Go to Brief Summary: This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS. Condition or disease Intervention/treatment Phase Polycystic Ovary Syndrome (PCOS) Drug: MLE4901 40mg Drug: Placebo Phase 2 Detailed Description: Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge (...) Placebo Comparator: Placebo Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets Drug: Placebo Placebo to match active drug Experimental: MLE4901 40mg Plain, round, biconvex, white film-coated tablets of 40 mg strength administered twice per day Drug: MLE4901 40mg Outcome Measures Go to Primary Outcome Measures : Menstrual Cycle Duration [ Time Frame: 28 Week double blind treatment period ] Assessment of the number of days between menstrual cycles from baseline

2016 Clinical Trials

190. Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)

not interfere with the participant's daily activities. Moderate: the attack symptoms interfered with the participant's ability to attend work/school or participate in family life and social/recreational activities and severe: the attack symptoms significantly limited the participant's ability to attend work/school or participate in family life and social/recreational activities. Number of participants with angioedema attacks in different anatomic locations in treatment period was compared to NNA (...) quality of life instrument. It consisted of 17 specific questions that were associated with work, physical activity, free time, social relations, and diet. Each of the 17 items had a 5-point response scale ranging from 1 (Never) to 5 (Very Often). The questionnaire was scored according to the developers' guidelines to produce a total score and 4 domain scores (functioning, fatigue/mood, fear/shame, nutrition). Raw domain scores (mean of the item scores within each scale) and the raw total score (mean

2016 Clinical Trials

191. Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer

cancer will be assayed. Safety and tolerability of SM88 in patients with prostate cancer. [ Time Frame: Six months ] Changes from baseline in blood work results and incidence of adverse events associated with treatment of SM88 in patients with prostate cancer. Anti-cancer activities of SM88 in patients with prostate cancer. [ Time Frame: Six Months ] Changes from baseline in CTCs, and PSA level per Prostate Cancer Working Group 3 (PCWG3) criteria and radiography per RECIST 1.1 criterial, stratified (...) by circulating tumor cells (CTC) and other blood-based markers including lactate dehydrogenase (LDH), total alkaline phosphatase, bone-specific alkaline phosphatase, urine N-telopeptide, hemoglobin, and neutrophil:lymphocyte ratio (NLR). Correlation of toxicity and efficacy with cutaneous hyperpigmentation [ Time Frame: Six Months ] The incident and severity (as assessed by CTCAE v4.0) of treatment-related adverse events and anticancer activities of SM88 are correlated with the degree of cutaneous

2016 Clinical Trials

192. Combined Letrozole and Clomid in Women With Infertility and PCOS

and Clomid in Women With Infertility and PCOS The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02802865 Recruitment Status : Active, not recruiting First Posted : June 16, 2016 Last Update Posted : December 5, 2018 Sponsor: Rachel Mejia Information provided by (Responsible Party): Rachel Mejia, University (...) of Infertility in Women With Polycystic Ovary Syndrome Study Start Date : August 2016 Actual Primary Completion Date : April 2018 Estimated Study Completion Date : February 2019 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: Letrozole Letrozole 2.5 mg orally for 5 days on cycle days 3-7 Drug: Letrozole Other Name: femara Experimental: Letrozole + Clomiphene Letrozole 2.5 mg

2016 Clinical Trials

193. Ulipristal Versus Placebo for Women With Bleeding Induced by Mirena

with contraceptive failure between 0.1 and 0.5/100 women/year. It released 20 mcg/day of LNG with a life span duration of 5 years. LNG is a synthetic progestin, 19-northestosterone, six times more potent than progesterone, with androgenic properties and with binding with sexual hormones, receptors of human steroids, including receptors of glucocorticoids and mineralocorticoids, with minimal capacity of binding with estrogen receptors. At endometrium level it induce antiproliferative effect and strong expression (...) at the dose of 5-10 mg as oral contraceptive. This could be an option of treatment for HMB or abnormal bleeding induced by the LNG-IUS. UPA is agonist/antagonist and binding with progesterone to the receptor level. It has ovarian and endometrial activity, with dose-dependent effect in inhibition of ovulation and maturation of the endometrium. There are restricted evidences, that the administration of UPA induce a quick endometrial atrophy and stop the abnormal bleeding. Study Design Go to Layout table

2016 Clinical Trials

194. Gestational Trophoblastic Disease

trophoblastic neoplasia (GTN). 2. Purpose and scope The purpose of this guideline is to describe the presentation, management, treatment and follow-up of GTD and GTN. It also provides advice on future pregnancy outcomes and the use of contraception. 3. Background and introduction Molar pregnancies can be subdivided into complete (CM) and partial moles (PM) based on genetic and histopathological features. Complete moles are diploid and androgenic in origin, with no evidence of fetal tissue. Complete moles (...) with molar pregnancy. There is theoretical concern over the routine use of potent oxytocic agents because of the potential to embolise and disseminate trophoblastic tissue through the venous system. This is known to occur in normal pregnancy, especially when uterine activity is increased, such as with accidental haemorrhage. 13 The contraction of the myometrium may force tissue into the venous spaces at the site of the placental bed. The dissemination of this tissue may lead to the profound deterioration

2010 Royal College of Obstetricians and Gynaecologists

195. TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy

with menopause and to investigate the systemic exposure to estradiol following once daily intravaginal administrations of TX-12-004-HR for 14 days. Postmenopausal subjects who met the study entry criteria were randomized to one of two treatment groups (TX-12-004-HR or Placebo). During the Screening period subjects were asked to self-assess the symptoms of vulvar and/or vaginal atrophy, including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity (...) and vaginal bleeding associated with sexual activity. Subjects with at least one self-assessed moderate to severe symptom of vulvar and/or vaginal atrophy identified by the subject as being most bothersome to her were eligible to participate in the study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 50 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary

2015 Clinical Trials

196. Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men

of the hypothalamic-pituitary axis; Known hypersensitivity to progestins or androgen; Family or personal history of venous thromboembolism; Benign or malignant liver tumors; active liver disease; Known history of reproductive dysfunction including vasectomy or infertility; Known history of cardiovascular, renal, hepatic or prostatic disease; A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above); Known or suspected (...) , 2015 Last Update Posted : May 14, 2018 Sponsor: Health Decisions Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Information provided by (Responsible Party): Health Decisions Study Details Study Description Go to Brief Summary: This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days. Condition or disease

2015 Clinical Trials

197. Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

Status : Active, not recruiting First Posted : May 4, 2015 Last Update Posted : August 9, 2018 Sponsor: Yale University Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Penn State University Augusta University University of California, San Francisco University of North Carolina University of Oklahoma University of Pennsylvania Information provided by (Responsible Party): Heping Zhang, Yale University Study Details Study Description Go to Brief (...) Summary: A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification program with tracked increased physical activity and weight loss (intensive) compared to recommendations to tracking of increased physical activity alone with weight maintenance (standard) in women with obesity and unexplained infertility. This 16 week period of lifestyle modification will be followed by an open label empiric infertility treatment regimen consisting of three cycles of ovarian

2015 Clinical Trials

198. The RCT of Acupuncture on PCOS Combined With IR

will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month. Drug: Placebo metformin Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month. Other Name: placebo Dimethylbiguanide Active Comparator: sham acupuncture + metformin Sham acupuncture and metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use (...) h excited test (after 60 min)) ⑤ Suspected androgen secreting adrenal or ovarian tumor. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome the last 2 months. Receiving acupuncture in the past 2 months. Within 6 weeks pregnancy. Post-abortion or postpartum within the past 6 weeks. Breastfeeding within the last 4 months. Not willing to give written consent to the study. Having a bariatric surgery procedure within the past 12 months or being

2015 Clinical Trials

199. The Clinical Trial of Acupuncture Pre-treatment on PCOS

following progestin, one time per day.Participants are treated for up to 4 cycles. Other Name: Letrozole(Femara, Novartis Pharmaceuticals) Active Comparator: Letrozole LE alone. LE will be started on day 3-5 after a spontaneous period or a withdrawal bleeding following progestin. The subjects will be instructed to have intercourse on a regular basis during the cycles. Drug: Letrozole Starting from 2.5mg daily from day 3-5 for 5 days after a spontaneous period or after a withdrawal bleeding following (...) Estimated Study Completion Date : December 2017 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Pre-treatment acupuncture + letrozole A 16 week acupuncture pretreatment followed by letrozole(LE). Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. All subjects will be requested to use contraception during

2015 Clinical Trials

200. Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery

will receive dienogest 2mg daily for 24 months postoperatively Other Name: Visanne Active Comparator: Combined oral contraceptive pills Drug: Microgynon The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months. Outcome Measures Go to Primary Outcome Measures : Recurrence of ovarian endometrioma [ Time Frame: 2 years ] Time to recurrence by sonography (months) Recurrence of ovarian endometrioma [ Time Frame: 2 years ] Size of recurrent endometrioma on sonography (mean (...) at least 6 weeks apart No contraindication to use of progesterone or combined oral contraceptive pills Not attempting to conceive either at the time of study entry or for at least 2 years after surgery Willing and able to participate after the study has been explained Exclusion Criteria: Operative findings not suggestive of endometriotic cyst Contraindications to progestogens or oral contraceptive pills Unwillingness to tolerate menstrual irregularity Planning pregnancy within 2 years of study Cannot

2015 Clinical Trials

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