Clinical trials: Healthy, Postmenopausal Women
Osteoporosis
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.
- Trial name
- NCT00709540
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Menopause, Healthy Female Participants
A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS.
- Trial name
- NCT07794150
- Testing
- Estradiol/Levonorgestrel Transdermal System
- Where
- 2 sites in United States, India
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Corium Innovations, Inc.
Postmenopausal Symptoms
Pharmacokinetic Evaluation of Brisdelle™ (Formerly Known as Mesafem) Following Single & Repeat Oral Administration in Healthy Postmenopausal Women
The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate) Capsules 7.5 mg when given as a single dose and…
- Trial name
- N30-005 (NCT01829919)
- Testing
- Brisdelle (paroxetine mesylate)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Noven Therapeutics
Menopause
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new…
- Trial name
- NCT00396799
- Testing
- bazedoxifene/conjugated estrogens
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Osteopenia
An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density
The purpose of this study is to assess the safety, tolerability, and potential immune response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose administrations in healthy men and postmenopausal women…
- Trial name
- NCT01101048
- Testing
- AMG 167
- Volunteers
- 74 people
- Sponsor
- Amgen
Healthy Volunteers
A Study of ACE-2494 in Healthy Subjects
The purpose of the study is to assess safety, tolerance, pharmacokinetic, and pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women.
- Trial name
- NCT03478319
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Healthy
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.
- Trial name
- NCT00550303
- Testing
- bazedoxifene/conjugated estrogens combination
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Osteoporosis
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
- Trial name
- NCT01011725
- Testing
- MK 0773
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day
The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy…
- Trial name
- NCT00649896
- Testing
- Mylan Estradiol Transdermal System 0.025 mg/day, Climara® Transdermal System 0.025 mg/day
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Osteoporosis
A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
- Trial name
- NCT00620854
- Testing
- Recombinant Salmon Calcitonin (rsCT), Oral Tablet, Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tarsa Therapeutics, Inc.
Muscular Atrophy
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.
- Trial name
- NCT00952887
- Testing
- ACE-031
- Where
- 2 sites in Canada
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Menopause, Healthy
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA)…
- Trial name
- NCT01477632
- Testing
- 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA), 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA), 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hypoactive Sexual Desire Disorder
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive…
- Trial name
- NCT01743235
- Testing
- Testosterone, Buspirone hydrochloride
- Where
- 12 sites in United States
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Emotional Brain NY Inc.
Postmenopause
Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA). About 24 subjects will take part in this study.
- Trial name
- NCT00367536
- Testing
- bazedoxifene/conjugated estrogens combination tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Osteoporosis
A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)
This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.
- Trial name
- NCT00770159
- Testing
- odanacatib
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Homeostasis, Bone and Bones
Effect of Dexlansoprazole on Bone Homeostasis
The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.
- Trial name
- NCT01216293
- Testing
- Dexlansoprazole, Esomeprazole
- Where
- 12 sites in United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Takeda
Primary Ovarian Insufficiency, Vaginitis
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Trial name
- NCT01436513
- Testing
- Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed)
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer
Clinical Trials, Phase I as Topic
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design.
- Trial name
- NCT02212080
- Testing
- BAY1214784
- Where
- 2 sites in Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bayer
Postmenopause
To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .
A Drug-Drug Interaction Study to Evaluate the Effect of Smoking (CYP1A2 Inducer) on the Pharmacokinetics Following a Single Oral Dose of GS1-144 Tablets in Chinese Healthy Postmenopausal Female Trial Participants
- Trial name
- NCT07534176
- Testing
- GS1-144 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Osteoporosis
A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy Women
This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women.
- Trial name
- NCT00540878
- Testing
- SB-751689 oral tablets (400 mg)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline