Clinical trials: Premenopausal
Menstruation Disorders
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol.
- Trial name
- NCT00467493
- Testing
- Anastrozole
- Where
- 2 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Meditrina Pharmaceuticals
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids…
- Trial name
- PRIMROSE 2 (NCT03070951)
- Testing
- OBE2109, Add-back
- Where
- 96 sites in United States, Bulgaria and 7 more
- Volunteers
- 511 people
- Sponsor
- ObsEva SA
Menorrhagia
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Abnormal uterine bleeding (AUB) is defined as "flow outside of normal volume, duration, regularity, or frequency". Acute AUB is excessive bleeding that requires immediate intervention to prevent further blood loss.
- Trial name
- AQTH-EA-PIV-24 (NCT07877051)
- Testing
- Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS)
- Where
- 3 sites in Georgia
- Volunteers
- 43 people
- Sponsor
- Aqua Therapeutics, Inc.
Uterine Fibroids
Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200
To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.
- Trial name
- NCT01739621
- Testing
- Proellex 12 mg, Proellex 24 mg
- Volunteers
- 40 people
- Sponsor
- Repros Therapeutics Inc.
Iron-deficiency
Safety and Effectiveness of Iron Hydroxide Adipate Tartrate (IHAT) in Iron Deficient Premenopausal Women
This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed Iron Hydroxide Adipate Tartrate (IHAT) at 2 different dose levels compared to placebo for increasing serum ferritin levels in iron deficient…
- Trial name
- NCT06285799
- Testing
- Low Dose IHAT, High Dose IHAT, Carob Flour
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Nemysis Ltd
Hypoactive Sexual Desire Disorder
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).
- Trial name
- NCT04943068
- Testing
- Bremelanotide
- Where
- South Korea
- Volunteers
- 193 people
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Breast Cancer
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone…
- Trial name
- NCT00375505
- Testing
- Zoledronic acid
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Lactating Mother
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC.
- Trial name
- NCT06867835
- Testing
- Vyleesi (Bremelanotide Injection)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cosette Pharmaceuticals, Inc.
Growth and Development
To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
To investigate the effect of nutritional supplement on bone turnover markers (which are sensitive and respond quickly to nutrition or drug intervention) in Indian healthy premenopausal women after 6 months of intervention.
- Trial name
- NCT03155269
- Testing
- Fortified Beverage Powder, Non fortified beverage Powder
- Where
- India
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Endometriosis
Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis
The primary purpose of this study is to determine the safety and efficacy of two oral doses of telapristone acetate administered to premenopausal women with pelvic pain associated with endometriosis confirmed within the last…
- Trial name
- NCT01728454
- Testing
- Telapristone acetate
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
Premenopausal Breast Cancer
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
- Trial name
- NCT03209518
- Testing
- Leuprorelin acetate
- Where
- Japan
- Volunteers
- 312 people
- Sponsor
- Takeda
Systemic Lupus Erythematosus
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
- Trial name
- NCT00739050
- Testing
- simvastatin
- Volunteers
- 4 people
- Sponsor
- Organon and Co
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim in Premenopausal Non-pregnant Females
This is an open-label, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant…
- Trial name
- NCT06893796
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Healthy Adult Premenopausal Female Volunteers
Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects
A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15…
- Trial name
- NCT02641990
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Intarcia Therapeutics
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Pergoveris FD and Liquid China BE Study
The main purpose of this study is to assess the bioequivalence (BE) of the fixed combination of follitropin alfa and lutropin alfa in Pergoveris freeze-dried (FD) (Test 1) or in Pergoveris Liquid (Test 2) versus the…
- Trial name
- NCT04899193
- Testing
- Pergoveris FD, Pergoveris Liquid, Gonal-f
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Endometriosis
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
ZPE-201 Extension of treatment
- Trial name
- NCT00958412
- Testing
- Proellex®
- Where
- 8 sites in United States
- Volunteers
- 18 people
- Sponsor
- Repros Therapeutics Inc.
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Endometriosis
A Study of HS-10518 in Healthy Female Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China.
- Trial name
- NCT06118827
- Testing
- HS-10518
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.