Clinical trials: Premenopausal
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
Estrogen Receptor Positive, HER2/Neu Negative
Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma, Stage IIA Breast Cancer
- Trial name
- NCT01776008
- Testing
- Akt Inhibitor MK2206, Anastrozole, Goserelin Acetate
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- National Cancer Institute (NCI)
Sexual Dysfunctions, Psychological
Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens
- Trial name
- NCT00601367
- Testing
- flibanserin flexible dose
- Where
- 68 sites in Austria, Belgium and 10 more
- Volunteers
- 480 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Uterine Fibroids
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to…
- Trial name
- NCT02323646
- Testing
- Telapristone Acetate
- Where
- 8 sites in United States
- Volunteers
- 42 people
- Sponsor
- Repros Therapeutics Inc.
Adult Idiopathic Generalized Osteoporosis
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.
- Trial name
- NCT02049866
- Testing
- Denosumab
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- Elizabeth Shane
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Menstrual Cycle, Exercise Treadmill
The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women
False positive results are commonly observed in women after exercise treadmill test (ETT). The effects of menstrual cycle on the results of ETT in premenopausal women have not been clearly defined.
- Trial name
- NCT05985980
- Testing
- Exercise Treadmill Test (ETT)
- Where
- Turkey (Türkiye)
- Volunteers
- 47 people
- Sponsor
- Istanbul Medeniyet University
Healthy
Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel
Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.
- Trial name
- NCT01941615
- Testing
- faldaprevir, Microgynon®, BI 207127
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Uterine Fibroids
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months).
- Trial name
- NCT00853567
- Testing
- Proellex
- Where
- 17 sites in United States
- Volunteers
- 71 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510 premenopausal women with Hormone Receptor-positive…
- Trial name
- NCT00201851
- Testing
- Tamoxifen, Surgery: Oophorectomy
- Where
- 9 sites in Morocco, Philippines and 1 more
- Volunteers
- 740 people
- Sponsor
- International Breast Cancer Research Foundation
Breast Cancer
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of…
- Trial name
- NCT00186121
- Testing
- Anastrozole (Arimidex), Goserelin (Zoladex)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Stanford University
Anorexia Nervosa, Osteoporosis
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.
- Trial name
- 1180 (NCT02475265)
- Testing
- estradiol 0.045 mg/levonorgestrel 0.015mg
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Massachusetts General Hospital
Breast Cancer
Premenopausal Endocrine Responsive Chemotherapy Trial
The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or…
- Trial name
- PERCHE (NCT00066807)
- Testing
- chemotherapy, exemestane, tamoxifen
- Where
- 6 sites in Hungary, Italy and 1 more
- Volunteers
- 29 people
- Sponsor
- ETOP IBCSG Partners Foundation
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
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
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT02691494
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 105 sites in United States, Canada
- Volunteers
- 378 people
- Sponsor
- AbbVie
Premenopausal Breast Cancer
A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal breast cancer
- Trial name
- NCT01546649
- Testing
- TAP-144-SR(6M), TAP-144-SR(3M)
- Where
- 15 sites in Japan
- Volunteers
- 167 people
- Sponsor
- Takeda
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Dense Breasts
RANKL Inhibition and Mammographic Breast Density
Data supporting a role for RANKL signaling in mammographic density and breast cancer development has begun to emerge, but clinical trial data providing definitive evidence that would allow the adoption of RANKL inhibition in…
- Trial name
- TRIDENT (NCT04067726)
- Testing
- Denosumab, Calcium, Vitamin D3
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Washington University School of Medicine
Hypoactive Sexual Desire Disorder
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the…
- Trial name
- HSDD (NCT02338960)
- Testing
- Bremelanotide
- Where
- 91 sites in United States, Canada
- Volunteers
- 714 people
- Sponsor
- Palatin Technologies, Inc