Clinical trials: Leiomyomata Uteri
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after…
- Trial name
- NCT01252069
- Testing
- PGL4001, progestin, drug free period
- Where
- 18 sites in Austria, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- PregLem SA
Uterine Leiomyomata (Fibroids)
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 Administered to Healthy Japanese Females
The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
- Trial name
- NCT00444704
- Testing
- PRA-027
- Where
- Japan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Uterine Leiomyomata (Fibroids)
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and…
- Trial name
- NCT00543790
- Testing
- PRA-027
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Fibroid Uterus, Leiomyoma
Study of Asoprisnil in the Treatment of Uterine Fibroids.
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156156
- Testing
- Asoprisnil
- Volunteers
- 149 people
- Sponsor
- Abbott
Uterine Fibroids
Post Market TRUST Study
This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.
- Trial name
- TRUST (NCT01563783)
- Testing
- Global Fibroid Ablation (GFA), Abdominal or Laparoscopic Myomectomy, Uterine Artery Embolization (UAE)
- Where
- Canada
- Volunteers
- 84 people
- Sponsor
- Acessa Health, Inc.
Fibroid
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential
The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential.
- Trial name
- NCT00427544
- Testing
- PRA-027
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
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
- NCT02654054
- Testing
- Elagolix, Estradiol/Norethindrone Acetate
- Where
- 96 sites in United States, Canada and 1 more
- Volunteers
- 413 people
- Sponsor
- AbbVie
Uterine Fibroids
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
- Trial name
- PEARLIV (NCT01629563)
- Testing
- PGL4001 5 mg, PGL4001 10 mg
- Where
- 49 sites in Belgium, Czechia and 9 more
- Volunteers
- 451 people
- Sponsor
- PregLem SA
Uterine Fibroids
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.
- Trial name
- NCT00958893
- Testing
- 25 mg Proellex
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Repros Therapeutics Inc.
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
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
Fibroid Uterus, Leiomyoma
Safety of Treatment of Uterine Fibroids With Asoprisnil
The objective of this study is to determine the long-term safety of asoprisnil in women with symptomatic uterine fibroids who completed the 6 month Study C02-037.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia
- Trial name
- NCT00156208
- Testing
- Asoprisnil
- Volunteers
- 166 people
- Sponsor
- Abbott