Clinical trials: Premenopausal
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
Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen.
- Conditions
- Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma, Stage IA Breast Cancer
- Trial name
- SOFT (NCT00066690)
- Testing
- Exemestane, Laboratory Biomarker Analysis, Oophorectomy
- Where
- 500 sites in United States, Canada and 1 more
- Volunteers
- 3,066 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast…
- Trial name
- NCT02154139
- Testing
- Leuprorelin acetate
- Volunteers
- 651 people
- Sponsor
- Takeda
BRCA1 Mutation, Breast Cancer
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
- Trial name
- NCT00700778
- Testing
- recombinant human chorionic gonadotropin, microarray analysis, immunohistochemistry staining method
- Where
- 3 sites in United States, Austria
- Volunteers
- 2 people
- Sponsor
- Fox Chase Cancer Center
Sexual Dysfunctions, Psychological
Flibanserin Versus Placebo in Premenopausal Women With HSDD
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.
- Trial name
- NCT00491829
- Testing
- 50 mg qhs, 100 mg
- Where
- 86 sites in Austria, Belgium and 11 more
- Volunteers
- 945 people
- Sponsor
- Sprout Pharmaceuticals, Inc
Breast Cancer
Breast Cancer Risk Biomarkers in Premenopausal Women
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.
- Trial name
- NCT01252277
- Testing
- Lovaza™
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Carol Fabian, MD
Uterine Fibroids
An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 [NCT02323646] or ZPU-203 [NCT02301897] and meet eligibility criteria.
- Trial name
- NCT02811159
- Testing
- Telapristone acetate
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Repros Therapeutics Inc.
Breast Cancer
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen.
- Trial name
- TEXT (NCT00066703)
- Testing
- exemestane, tamoxifen, triptorelin
- Where
- 228 sites in United States, Australia and 15 more
- Volunteers
- 2,672 people
- Sponsor
- ETOP IBCSG Partners Foundation
IOP, Osteoporosis
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopathic osteoporosis (IOP)…
- Trial name
- NCT03396315
- Testing
- Alendronate, Zoledronic Acid
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Columbia University
Breast Cancer Invasive Nos
TRial on the Endocrine Activity of Neoadjuvant Degarelix
The purpose of the this study is to investigate the anti-tumor activity and tolerability of the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative treatment with Letrozole.
- Trial name
- TREND (NCT02005887)
- Testing
- triptorelin, degarelix, letrozole
- Where
- 7 sites in Italy
- Volunteers
- 51 people
- Sponsor
- ETOP IBCSG Partners Foundation
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.
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
Japanese Premenopausal Healthy Adult Women
A Food Effect Study of TAK-385 Final Formulation
The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.
- Trial name
- NCT02792062
- Testing
- TAK-385 40 mg
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Breast Cancer
S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
- Trial name
- NCT00088972
- Testing
- celecoxib
- Where
- 9 sites in United States
- Volunteers
- 8 people
- Sponsor
- SWOG Cancer Research Network
Hepatitis C, Chronic
Drug-drug Interaction of BI 201335 and Microgynon
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
- Trial name
- NCT01570244
- Testing
- levonorgestrel, Ethinylestradiol, BI 201335
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
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
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.
Healthy
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
The objective of this study is to investigate the possible effect of multiple oral doses of 25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and levonogestrel (LNG) (Microgynon®).
- Trial name
- NCT01328184
- Testing
- levonorgestrel, Ethinylestradiol, Microgynon + BI 10773
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim