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Progestin Androgenic Activity

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141. 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

142. Efficacy and safety of transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder: a systematic review and meta-analysis. (PubMed)

, sexual activity, orgasms, desire, significant change in Personal Distress Scale score, androgenic adverse events, acne, and hair growth compared with the placebo group. There was no significant difference between the two groups in increase in facial hair, alopecia, voice deepening, urinary symptoms, breast pain, headache, site reaction to the patch, total adverse events, serious adverse events, reasons for withdrawal from the study, and the number of women who completed the study.The short-term (...) efficacy in terms of improvement of sexual function and safety of transdermal T in naturally and surgically menopausal women affected by HSDD either on or not on estrogen progestin hormone therapy is evident from this systematic review. The use of transdermal T is associated with increase in androgenic adverse events such as acne but is not associated with any serious adverse events.Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

2016 Fertility and Sterility

143. Male Hormonal Contraception: Where Are We Now? (PubMed)

include acne, injection site pain, mood change including depression, and changes in libido that are usually mild and rarely lead to discontinuation. Current development includes long-acting injectables and transdermal gels and novel androgens that may have both androgenic and progestational activities. Surveys showed that over 50 % of men will accept a new male method and female partners will trust their partner to take oral "male pills." Partnership between government, nongovernment agencies (...) Male Hormonal Contraception: Where Are We Now? Hormonal male contraception clinical trials began in the 1970s. The method is based on the use of exogenous testosterone alone or in combination with a progestin to suppress the endogenous production of testosterone and spermatogenesis. Studies using testosterone alone showed that the method was very effective with few adverse effects. Addition of a progestin increases the rate and extent of suppression of spermatogenesis. Common adverse effects

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2016 Current obstetrics and gynecology reports

144. Progesterone

. Types (e.g. Ortho-Novum) (Enovid) (e.g. Loestrin) (e.g. Demulen) (e.g. ) dl- (e.g. Ovral) (e.g. ) (e.g. ) Chlormadinone acetate Megestrol acetate acetate III. Adverse Effects: Hyperlipidemia Overall Effect Lowers HDL-2 to ratio Factors related to unfavorable HDL effects Higher Lower to Progestin ratio Progestins most adversely effecting lipid (androgen) Progestins with most favorable lipid effects Progestin only formulations (mini pill) (low dose) IV. References Dickey (1998) Managing Contraceptive (...) Progesterone Progesterone Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Progesterone Progesterone Aka: Progesterone , Progestin II

2018 FP Notebook

145. Starting a Testosterone and Exercise Program After Hip Injury

or androgen containing compound within the previous 6 months. Treatment with systemic corticosteroids (daily dose > 5 mg prednisone or equivalent) for at least 90 days within the previous 12 months. Visual or hearing impairments that interfere with following directions for research procedures. Active or unstable cardiopulmonary disease (recent MI, unstable angina, class III or IV CHF) within prior 6 months, which would limit full participation in the study. Respiratory disease requiring chronic continuous (...) following a hip fracture has been documented as late as a year after the fracture, even among women who were functioning at high levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass, strength and power that are common in this patient population before the fracture, and are exacerbated afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has demonstrated the feasibility of T treatment in this population

2016 Clinical Trials

146. 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

147. Locally recurrent or metastatic breast cancer

inhibitor antidepressants (e. g. paroxetine, ?uoxetine). Fulvestrant at the dose of 500mg every 4 weeks has demonstrated superiority compared with anastrozole in the ?rst-line setting [II, A]. Second and further lines of endocrine therapy may include (if not previously used) tamoxifen, steroidal or nonsteroidal AIs, fulvestrant, progestins (e.g. megestrol acetate) and androgens. No de?nitive recommendation can be given for a speci?c endocrine treatment cascade, and particularly, the best option after (...) patients, whenever available. The vast majority of MBC is incurable and hence the main treatment goal is palliation, with the aim of maintaining/ improving quality of life and possibly prolonging survival. The realistic treatment goals should be discussed with the patient and her/his caregivers from the beginning and the patient should be encouraged to actively participate in all decisions. Patient preferences should always be taken into account. Systemic treatment options for MBC are endocrine therapy

2012 European Society for Medical Oncology

148. Hot Flashes and Night Sweats (PDQ®): Health Professional Version

of hot flashes.[ ][ ] Risk associated with progestin use is unknown.[ ] Other Pharmacologic Interventions Numerous nonestrogenic, pharmacologic treatment interventions for hot flash management in women with a history of breast cancer and in some men who have undergone androgen deprivation therapy have been evaluated. Options with reported efficacy include androgens, progestational agents, gabapentin, SSRIs, selective serotonin norepinephrine inhibitors, alpha adrenergic agonists (e.g., methyldopa (...) , radiation therapy, or androgen treatment. Causes of “male menopause” include orchiectomy, gonadotropin-releasing hormone use, or estrogen use. Drug-associated causes of hot flashes and night sweats in men and women include tamoxifen, aromatase inhibitors, opioids, tricyclic antidepressants, and steroids. Women who are extensive metabolizers of tamoxifen related to CYP2D6 may have more severe hot flashes than women who are poor metabolizers.[ ] References Lynn Henry N, Rae JM, Li L, et al.: Association

2015 PDQ - NCI's Comprehensive Cancer Database

149. Q&A Potpourri ? Osteoporosis, Vit D, Self-Monitoring of Blood Glucose, and Anti-Infectives

) 750ug/3mL prefilled pen syringe - anabolic: ? osteoblast activity {PTH I-84 PreOs} avail in Europe Forteo Customer Care Program: 1-877-436-7836 Possible financial assistance by Eli Lilly. Common vs pl : Nausea 9vs7% ,dizzy 8vs5% ,cramp leg 3vs1% ,syncope 3vs1% Serious vs placebo : Osteosarcoma rats , hypercalcemia symptomatic (eg. nausea, vomiting, constipation, lethargy, muscle weakness) , hyperuricemia 3 vs 0.7% , angina pectoris 3vs2% , arthralgia 10vs8% , tooth disorder 2vs1% CI: Pre-existing (...) C, et al. Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study. J Bone Miner Res 2008;23:525-535. Mosca L, Grady D, Barrett-Connor E, et al. Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease. Stroke 2009; 40(1):147-155. NAMS: North American Menopause Society. Management of osteoporosis

2010 RxFiles

150. Addyi - Flibanserin

, characterized by a deficiency or absence of sexual fantasies and desire for sexual activity (criterion A)” that causes “marked distress or interpersonal difficulty (criterion B).” 1 Additionally, this disorder cannot be better accounted for by a general medical, other psychiatric, or a substance or drug-related condition (criterion C). HSDD is classified as either acquired (symptoms beginning after a period of relatively normal sexual function) or lifelong (present since the individual became sexually (...) active); in addition, HSDD can be either generalized (not limited to certain types of stimulation, situations, or partners) or situational (only occurs with certain types of stimulation, situations or partners). HSDD, along with disorders of arousal, orgasm, and sexual pain in women, are 1 Diagnostic and statistical manual of mental disorder (DSM), Washington, DC: American Psychiatric Association: DSM-III-R, published in 1987; DSM-IV, published in 1994; DSM-IV, primary care version, published in 1995

2015 FDA - Drug Approval Package

151. Senshio - ospemifene

to the pharmacological action of metabolite M-1, compared to humans. The potency of M-1 regarding effects on rat vaginal and uterine tissue, however, was largely similar to that of the parent compound. In vitro receptor selectivity Based on limited competitive binding data it was considered possible that both the progesterone receptor and the androgen receptor contribute to effects of Ospemifene, and that the progesterone receptor contributes to effects of metabolites M-1 and M-2. In vitro receptor activation In two (...) Procedure No. EMEA/H/C/002780/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/78875/2015 Page 2/116 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Manufacturers 8 1.3. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Introduction 9 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 11 2.2.3. Finished

2015 European Medicines Agency - EPARs

152. Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas

. In the world literature we have reported several studies that demonstrate the effectiveness of different groups of drugs such as oral contraceptives, progestins, GnRH analogues and danazol. Within the available scientific evidence it has been extensively described the benefits of the new progestins Dienogest, demonstrating a favorable safety profile and efficacy along with a significant reduction of the symptoms of the disease by its anti-inflammatory, and antiproliferative antiagiogénicas (...) 2015 Estimated Primary Completion Date : November 2017 Estimated Study Completion Date : November 2018 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Dienogest the patient handling with 2 mg dienogest / day. Drug: Dienogest patients assigned to this treatment receive 2 milligrams per day Other Name: visanne Active Comparator: Levonorgestrel + ethinylestradiol The patient handling

2015 Clinical Trials

153. DAPA, EQW, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)

(statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, gonadotropin-releasing hormone agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finasteride, spironolactone, flutamide) stopped for at least 4 weeks Prior history (...) oral pill daily with food for 24 weeks Drug: Dapagliflozin plus Glucophage (MET ER) DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose Other Names: Xigduo •Combination SGLT2 inhibitor and metformin ER Active Comparator: Phentermine /Topiramate (PHEN/ TRP) ER Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks Drug: Phentermine /Topiramate (PHEN/ TRP) ER PHEN 3.75/TRP ER

2015 Clinical Trials

154. Ulipristal Acetate In Disease Charcot-Marie-Tooth Type of 1A

of glutathione S-transferase theta 2 and Cathepsin A (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in the prognosis evolution of the disease. Furthermore, several studies have shown that the administration of progesterone increased the expression of PMP22 gene (measured in a skin biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22 and improve symptoms in rat CMT1A. The long-term safety of anti-progesterone was evaluated (...) for mifepristone (RU486) ulipristal acetate and (EllaOne®). Few side effects have been reported including a few cases of endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare cases of adrenal androgen and failure have been observed. However, EllaOne® has low antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The investigators therefore believe that it will be well tolerated in humans and will reduce the synthesis of PMP22 and the action

2015 Clinical Trials

155. Oral Contraceptive Therapy and Sexuality

Maggi, University of Florence Study Details Study Description Go to Brief Summary: Oral contraceptives (OCs) ameliorate hyperandrogenism and regulate menstrual cycles. To reduce androgenic side effects of first- and second-generation progestins, several new progestins derived from progesterone or spironolactone have been developed in the last few decades. These progestins, such as drospirenone, cyproterone acetate and NOMAC, are designed to bind specifically to the progesterone receptor and to have (...) no androgenic, estrogenic or glucocorticoid actions. However, OCs with a more pronounced anti-androgenic effects are more likely to induce sexual dysfunction, mainly hypoactive sexual desire disorder, which can highly impact patient and partner's quality of life. Moreover, available data indicate that OC use might increase adiposity in adolescents and might be associated with central redistribution of body fat in young women with Polycystic ovary syndrome (PCOS) without a recognizable difference in clinical

2015 Clinical Trials

156. Fetal Effects of Pre-Pregnancy Lifestyle Interventions in Unexplained Infertility Patients

if they conceive. Condition or disease Intervention/treatment Infertility Dietary Supplement: Alli-nutritional supplement Detailed Description: Via participation in the FIT-PLESE study (from the RMN) we will randomize 90 obese women with unexplained infertility 1:1 to a lifestyle modification program consisting of nutritionally balanced caloric restriction (1200-1500 kcal/d), a gastric lipase inhibitor (Alli) and increased physical activity (with a goal of reaching 10K steps/d) (NuPA) versus increased physical (...) activity alone (PAo). The pre-pregnancy intervention lasts 16 weeks, with a goal of 7% weight loss in the NuPA arm. Weight and physical activity are monitored with wireless devices (Fitbit Wireless Activity Tracker and Fitbit Aria Wireless Activity Scale, respectively). Following the 16 week pre-pregnancy intervention, all randomized couples will undergo standard treatment for unexplained infertility, 3 cycles of CC-IUI (requiring ~3 months). The goal for both treatment groups is to maintain levels

2015 Clinical Trials

157. COrticosteroid in Congenital Adrenal Hyperplasia

, and effectively curb the adrenal hyperplasia and adrenal androgen pathway in girls . The terms of glucocorticoid treatment are not clearly codified and are based on several steroidal compounds and various protocols. The advantages in terms of adrenal suppression and disadvantages - including bone and metabolic - different treatments have not been clearly established in the literature. The main objective of this study is to compare among adults with HCS in its classical form the impact on hormonal parameters (...) Eligible for Study: 18 Years to 55 Years (Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Pubescent women over 18 in genital activity (premenopausal) Suffering from congenital adrenal hyperplasia in its classical form with salt loss or pure virilizing Patients who have presented signs of congenital adrenal hyperplasia in its classical form (salt wasting syndrome and / or neonatal masculinization) with elevation of 17 OH progesterone with diagnosis

2015 Clinical Trials

158. 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

159. 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

160. 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

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