Clinical trials: Women
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer…
- Trial name
- OASIS-4 (NCT05587296)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 102 sites in Austria, Belgium and 14 more
- Volunteers
- 474 people
- Sponsor
- Bayer
Non-alcoholic Fatty Liver Disease in Women With PCOS
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
- Trial name
- NCT03617263
- Testing
- Saroglitazar Magnesium 4 mg Tablet
- Where
- 19 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Zydus Therapeutics Inc.
Recurrent Urinary Tract Infection in Adult Women
Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection in Adult Women
Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime.
- Trial name
- NCT03366077
- Testing
- Probiotic
- Where
- Sweden
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- BioGaia AB
Postmenopausal Women With Osteoporosis
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with…
- Trial name
- DEVOTE (NCT05345691)
- Testing
- Bmab 1000, Prolia®
- Where
- United Kingdom
- Volunteers
- 479 people
- Sponsor
- Biocon Biologics UK Ltd
Women at Risk for Pregnancy
Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS
To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept
- Trial name
- NCT03633799
- Testing
- VeraCept
- Where
- 41 sites in United States
- Volunteers
- 1,620 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Women at Risk for Pregnancy
A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)
to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women
- Trial name
- IUD (NCT03785366)
- Testing
- VeraCept, ParaGard
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Postpartum, Women
Monitoring and Outreach for Maternal Safety Postpartum
Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for…
- Conditions
- Postpartum, Women, Community Health Workers, Knowledge
- Trial name
- MOMSPostpartum (NCT06899737)
- Testing
- MOMS Postpartum Course
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- KDH Research & Communication
Healthy Lactating Women
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily…
- Trial name
- NCT06021951
- Testing
- Bempedoic Acid 180 MG Oral Tablet, Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Esperion Therapeutics, Inc.
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Postmenopausal Women With Osteoporosis
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.
- Trial name
- ARCH (NCT01631214)
- Testing
- Romosozumab, Alendronate
- Where
- 316 sites in United States, Argentina and 40 more
- Volunteers
- 4,093 people
- Sponsor
- Amgen
Postmenopausal Women With Osteoporosis
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis
- Trial name
- NCT04757376
- Testing
- CT-P41, US-licensed Prolia
- Where
- 20 sites in Estonia, Latvia and 2 more
- Volunteers
- 479 people
- Sponsor
- Celltrion
Healthy Lactating Women
Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women
This is an open label, single treatment, multiple doses lactation study of SPN-812 in healthy lactating women. The study is designed to assess the excretion of viloxazine and its major metabolite 5-HVLX-gluc into breast milk…
- Trial name
- SPN-812 (NCT06259331)
- Testing
- SPN-812 (600mg, QD)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Supernus Pharmaceuticals, Inc.
Postmenopausal Women With Osteoporosis
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and…
- Trial name
- NCT03974100
- Testing
- GP2411, EU-Prolia (EU-authorized Prolia®)
- Where
- 42 sites in United States, Bulgaria and 4 more
- Volunteers
- 527 people
- Sponsor
- Sandoz
Women Who Have Had Breast Enhancement With Macrolane VRF
Macrolane Retrospective Study
This is a retrospective, multicenter chart review of medical records on the use of Macrolane for female breast enhancement. The primary objective is to evaluate the safety profile of Macrolane Volume Restoration Factor 20 and…
- Trial name
- NCT01223963
- Where
- 4 sites in Sweden
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women
Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women
To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.
- Trial name
- NCT02940522
- Testing
- Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
- Where
- 5 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- AMAG Pharmaceuticals, Inc.
Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women
Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women
To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®
- Trial name
- NCT02937766
- Testing
- Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AMAG Pharmaceuticals, Inc.
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to…
- Trial name
- STRENGTH (NCT02104817)
- Testing
- Epanova® (omega-3 carboxylic acids), corn oil control
- Where
- 684 sites in United States, Australia and 20 more
- Volunteers
- 13,078 people
- Sponsor
- AstraZeneca
Postmenopausal Women, Locally Advanced Metastatic Breast Cancer
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression on Tamoxifen, Anastrozole or…
- Conditions
- Postmenopausal Women, Locally Advanced Metastatic Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT01231659
- Testing
- Everolimus, Letrozole
- Where
- 7 sites in Israel
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Lactating Women
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in healthy lactating women. The objectives are to determine whether pregabalin is secreted in breast milk and if so, to characterize…
- Trial name
- NCT01727791
- Testing
- pregabalin (Lyrica)
- Where
- Belgium
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Progesterone Supplementation in Women Undergoing ART
Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART).
- Trial name
- SARA (NCT03565211)
- Testing
- Progesterone vaginal ring
- Where
- 15 sites in United States
- Volunteers
- 352 people
- Sponsor
- Ferring Pharmaceuticals