UMIN ID: UMIN000000879
Registered date:01/01/2008
Randomized controlled trial of efficacy and safety of pre-operative GnRH agonist administration for laparoscopic myomectomy.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | uterine fibroid |
| Date of first enrollment | 2006/10/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | leuprorelin acetate 1.88mg/month no administration of GnRHa |
Outcome(s)
| Primary Outcome | The rate of myomas at 6 months after GnRHa administration. The side effects during GnRHa administration. The estimated bleeding during operation, duration of operation and the weight of extracted specimens. |
|---|---|
| Secondary Outcome | The recurrence rate evaluated by MRI after LM. Pregnancy outcome after LM. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 45years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Patients with a history of hypersensitivity to ingerdients of the investigational drug or to any synthetic LH-RH agent or LH-RH derivative Women sho are or potentially may be pregnant Lactating women Women with non-diagnosable, abnormal bleedng of unknown origin |
Related Information
| Primary Sponsor | Dept. of OB/GY Juntendo univ. school of medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Iwaho Kikuchi ,MD |
| Address | Hongo 2-1-1 Bunkyo-ku Tokyo Japan Japan |
| Telephone | 03-3813-3111 |
| kikuchi@med.juntendo.ac.jp | |
| Affiliation | Juntendo univ. school of medicine OB/GY |
| scientific contact | |
| Name | Hiroyuki Takeuchi ,MD |
| Address | Hongo 2-1-1 Bunkyo-ku Tokyo Japan Japan |
| Telephone | |
| Affiliation | Juntendo univ. school of medicine ob. & gy |