Clinical trials: Premenopausal
Breast Cancer
HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.
The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500 patients, the study began recruiting premenopausal patients only.
- Trial name
- HOBOE (NCT00412022)
- Testing
- tamoxifen, triptorelin, letrozole
- Where
- 20 sites in Italy
- Volunteers
- 1,294 people
- Sponsor
- National Cancer Institute, Naples
Breast Cancer, Weight Loss
Low Fat Versus Protein Sparing Diet for Weight Loss & Impact on Biomarkers Associated With Breast Cancer Risk
The primary specific aim of this study was to determine if overweight and obese premenopausal women can lose weight and if long term weight loss impacts biomarkers associated with breast cancer risk.
- Trial name
- LEAF (NCT01559194)
- Testing
- Low Fat Diet plus exercise, Low Carbohydrate diet + Exercise
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Ohio State University Comprehensive Cancer Center
Abnormal Uterine Bleeding, Chronic Pelvic Pain
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical…
- Conditions
- Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female
- Trial name
- NCT03638856
- Testing
- Misoprostol 200Mcg Tab
- Where
- Thailand
- Volunteers
- 17 people
- Sponsor
- Department of Medical Services Ministry of Public Health of Thailand
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Breast Cancer
A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus…
- Trial name
- PREcoopERA (NCT05896566)
- Testing
- Giredestrant, Triptorelin, Anastrozole
- Where
- 37 sites in France, Germany and 4 more
- Volunteers
- 231 people
- Sponsor
- ETOP IBCSG Partners Foundation
Mastalgia
External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia
This is a single-center, double-blind, randomized clinical trial to explore the efficacy and safety of external mastalgia-oil versus placebo in premenopausal women with severe mastalgia.
- Trial name
- NCT06966245
- Testing
- mastalgia-oil
- Where
- China
- Volunteers
- 190 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Overweight
Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women
The purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous…
- Trial name
- CHOIX (NCT01240499)
- Testing
- Health-At-Every-Size (HAES)
- Where
- Canada
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Laval University
Breast Cancer, Osteoporosis
Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer.
- Trial name
- NCT00049452
- Testing
- zoledronic acid
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Herbert Irving Comprehensive Cancer Center
Breast Cancer
Pharmacodynamic Study Goserelin 3.6mg Injection Administered Subcutaneously in Premenopausal Patients with Breast Cancer
A two arm, multi centric, randomized, open label, parallel, multiple dose pharmacodynamic study in premenopausal patients with advanced breast cancer.
- Trial name
- NCT03936933
- Testing
- Goserelin acetate 3.6 mg Injection, ZOLADEX® 3.6mg Injection
- Where
- India
- Volunteers
- 6 people
- Sponsor
- Eurofarma Laboratorios S.A.
Healthy
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
This was a randomized, open-label, repeat dose study of once daily relugolix alone or relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone acetate) (E2/NETA) to assess safety, including markers…
- Trial name
- NCT04978688
- Testing
- Relugolix, E2/NETA
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Myovant Sciences GmbH
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 people
- Sponsor
- Novartis Pharmaceuticals
Menopause, Normal Physiology
Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer
Background: Incidence of breast cancer is very low in Mongolia (6.6/100,000), especially in rural areas. Over the past 15 years, there has been considerable economic growth in Mongolia, resulting in migration to urban centers…
- Trial name
- NCT00860886
- Where
- Mongolia
- Volunteers
- 412 people
- Sponsor
- National Cancer Institute (NCI)
Sexual Dysfunctions, Psychological
Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria.
- Trial name
- NCT00360555
- Testing
- flibanserin, flibanserin 50mg, flibanserin 100mg
- Where
- 77 sites in United States, Canada
- Volunteers
- 1,584 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Urge Incontinence, Urgency-frequency Syndrome
The Effect of Solifenacin Used for Lower Urinary Tract Symptoms on Sexual Function
This study aims to determine whether Solifenacine used for lower urinary tract symptoms improves sexual function and if so does this improvement differs between premenopausal and postmenopausal women.
- Trial name
- NCT05391425
- Testing
- no intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 150 people
- Sponsor
- Istanbul University
Uterine Fibroids
Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
- Trial name
- NCT00737282
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 25 sites in United States
- Volunteers
- 175 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Adjuvant Treatment in Premenopausal Breast Cancer
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
- Trial name
- PERSEVEREX (NCT06807749)
- Where
- 2 sites in Italy
- Volunteers
- 800 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Insulin Sensitivity/Resistance, Breast Cancer
Insulin Sensitivity After Breast Cancer
Epidemiological studies have revealed that 60-80% of women with breast cancer (BC) develop metabolic disorders that are similar to those observed in conditions like type 2 diabetes.
- Conditions
- Insulin Sensitivity/Resistance, Breast Cancer, Survivorship, Metabolic Disturbance
- Trial name
- NCT05010356
- Testing
- Insulin
- Where
- Denmark
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Uterine Bleeding
Role of Office Hysteroscope in Premenopausal Uterine Bleeding
The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old.
- Trial name
- NCT03205111
- Volunteers
- 100 people
- Sponsor
- Assiut University
Breast Cancer
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for…
- Trial name
- NCT00605267
- Testing
- Tamoxifen, Anastrazole (Arimidex), Goserelin acetate (Zoladex)
- Where
- 4 sites in Japan
- Volunteers
- 197 people
- Sponsor
- AstraZeneca
Endometriosis
Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis
The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.
- Trial name
- NCT00556075
- Testing
- Proellex 25 mg, Proellex 50 mg
- Where
- 17 sites in United States
- Volunteers
- 67 people
- Sponsor
- Repros Therapeutics Inc.