Clinical trials: Premenopausal
Female Sexual Dysfunction
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.
- Trial name
- NCT01364623
- Testing
- Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose, High dose testosterone nasal gel, single dose
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Acerus Pharmaceuticals Corporation
Breast Cancer
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause.
- Trial name
- NCT00823654
- Testing
- Blood draw and questionnaires
- Where
- 8 sites in United States
- Volunteers
- 609 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Nausea
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.
- Trial name
- NCT03973047
- Testing
- Bremelanotide, Zofran
- Where
- United States
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- AMAG Pharmaceuticals, Inc.
Heavy Menstrual Bleeding, Uterine Fibroids
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This randomized multicenter phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT03271489
- Testing
- Elagolix, Estradiol /norethindrone acetate (E2/NETA)
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 478 people
- Sponsor
- AbbVie
Breast Cancer
Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.
- Trial name
- SOFT-EST (NCT00975676)
- Testing
- gas chromatography / tandem mass spectometry
- Where
- 24 sites in France, Hungary and 6 more
- Volunteers
- 123 people
- Sponsor
- ETOP IBCSG Partners Foundation
Ovarian Failure
Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide
The use of adjuvant chemotherapy in younger women with early breast cancer (EBC) has substantially improved the long-term outcome.
- Trial name
- NCT03475758
- Testing
- Goserelin
- Volunteers
- 100 people
- Sponsor
- Assiut University
Polycystic Ovary Syndrome
Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women
Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS.
- Trial name
- NCT01319162
- Testing
- Weight reduction regimen
- Where
- Sweden
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Göteborg University
Hot Flashes
Understanding Experimentally Induced Hot Flushes
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a…
- Trial name
- NCT00455689
- Testing
- Leuprolide acetate
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Aquacycling
Aquatic Exercise and Metabolism in Women
Exercise training on an immersible ergocycle is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level.
- Trial name
- NCT02895217
- Testing
- ergocycle
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Clermont-Ferrand
Overweight and Obesity
Onsite vs. Virtual Group Fitness in Overweight/Obese Women
The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study…
- Trial name
- NCT04974476
- Testing
- HIIT Exercise Training
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Miami
Breast Cancer
Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2 negative, lymph node positive, primary breast…
- Trial name
- NEST (NCT01622361)
- Testing
- Adriamycin+Cyclophosphamide>Docetaxel, GnRHa with Tamoxifen
- Where
- South Korea
- Volunteers
- 290 people
- Sponsor
- Asan Medical Center
Premenopausal Breast Cancer, Hormone Receptor-positive Breast Cancer
Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients
MORE-T trial is designed to investigate the effect of Tamoxifen 40mg (vs. Tamoxifen 20mg) for 2wks in presurgical setting. The greater reduction in Ki-67 might be observed in Tamoxifen 40mg arm compared to the Tamoxifen 20mg arm.
- Trial name
- MORE-T (NCT04997941)
- Testing
- Tamoxifen Oral Product, Assessment of Ki-67, Surgery
- Where
- South Korea
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Obesity
Relationships Between GLP-2 and Markers of Bone Turnover Following Feeding
This study has been designed to study differences bone turnover in relation to glucagon-like peptide-2 (GLP-2) following feeding in lean and obese premenopausal women.
- Trial name
- GLP-2 (NCT01531907)
- Testing
- Study visit procedures
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
Vaginal Dysbiosis
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in…
- Trial name
- DISPALOMA (NCT06668012)
- Testing
- Palomacare® vaginal gel is a medical device with CE class IIa.
- Where
- 2 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Procare Health Iberia S.L.
Breast Cancer
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer
It has been found that many breast cancers are hormone dependent and that hormonal therapy by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has proven beneficial in both adjuvant and neoadjuvant…
- Trial name
- NCT00488722
- Testing
- Zoladex
- Where
- China
- Sponsor
- Tianjin Medical University
Breast Cancer Invasive
Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women Premise - MMG density as a surrogate marker of hormone therapy Assumption - "Add on OFS…
- Trial name
- NCT03664895
- Testing
- Leuplin or zoladex
- Where
- South Korea
- Volunteers
- 224 people
- Sponsor
- Seoul National University Hospital
Healthy
This Study Tests in Healthy Korean Women Which Effects BI 409306 and a Birth-control Pill Have on Each Other
The primary objective of this trial is to investigate the effect of multiple doses of ethinylestradiol / levonorgestrel (Microgynon®) on single dose pharmacokinetics of BI 409306 and the effect of single dose of BI 409306 on…
- Trial name
- NCT03193307
- Testing
- Microgynon® 30, BI 409306
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Heavy Uterine Bleeding, Uterine Fibroids
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women…
- Trial name
- NCT01817530
- Testing
- Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate, 1 mg estradiol / 0.5 mg norethindrone acetate
- Volunteers
- 571 people
- Sponsor
- AbbVie
Skin Aging, Weight Loss
Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women.
- Trial name
- NCT00352157
- Testing
- Revival Soy Dietary Supplement
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Physicians Pharmaceuticals, Inc.