A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women
NCT06908707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-11-17
Summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women
Conditions
- Postmenopausal
- Healthy Adult Female Participants
Interventions
- DRUG
-
LAE102 SC
A single dose of LAE102 will be administered subcutaneously
- DRUG
-
Placebo SC
A single dose of placebo administered subcutaneously
- DRUG
-
LAE102 IV
A single dose of LAE102 administered intravenously
- DRUG
-
Placebo IV
A single dose of placebo administered intravenously
Sponsors & Collaborators
- collaborator INDUSTRY
-
Laekna Limited
lead INDUSTRY
Principal Investigators
-
Dr. Hugh Coleman, MD · Fortrea Clinical Research Unit Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 45 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-22
- Primary Completion
- 2025-10-23
- Completion
- 2025-10-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants
NCT04903821 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison of Estradiol Vaginal Cream to Estrace® Cream in 350 Postmenopausal Females With Atrophic Vaginitis
NCT02195986 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
NCT06385795 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
NCT07118891 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
NCT00799708 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Aspects of 25-mg Estradiol Pellet in Climacteric Women
NCT06136208 ·Status: COMPLETED ·Phase: NA
-
Study of Erenumab (AMG 334) in Women With Hot Flashes
NCT01890109 ·Status: COMPLETED ·Phase: PHASE1
-
Raloxifene Use for The Heart
NCT00190593 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)
NCT01015677 ·Status: TERMINATED ·Phase: PHASE2
-
Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
NCT00251082 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
NCT05030584 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms
NCT03596762 ·Status: COMPLETED ·Phase: PHASE2
-
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
NCT00550303 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Study to Evaluate the Safety of Ospemifene
NCT00566982 ·Status: COMPLETED ·Phase: PHASE3
-
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
NCT00465894 ·Status: COMPLETED ·Phase: NA
-
Low-dose Hormone Therapy for Relief of Vasomotor Symptoms
NCT00446199 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
NCT02638337 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
NCT00543790 ·Status: COMPLETED ·Phase: PHASE1
-
Hormone Replacement Therapy for Use in Postmenopausal Women for Relief of Hot Flushes and Urogenital Symptoms.
NCT01070979 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Ospemifene on Pelvic Vascularity and Blood Flow
NCT02010580 ·Status: WITHDRAWN
-
A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women
NCT06219902 ·Status: COMPLETED ·Phase: PHASE1
-
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women
NCT03291067 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause
NCT05042362 ·Status: COMPLETED ·Phase: PHASE3
-
Impact of Estradiol on Endothelial Function in Peri-Menopausal Women
NCT04255160 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years
NCT05381142 ·Status: COMPLETED ·Phase: PHASE1