Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184795
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-09-13
Brief Title:
Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Six Month Double-blind Randomised Parallel-group Placebo-controlled Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 05 mg Estradiol and 01 mg or 025 mg Norethisterone Acetate Activelle Low Dose 01Activelle Low Dose 025 for Treatment of Menopausal Symptoms
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHOICE
Brief Summary:
This trial is conducted in Europe Postmenopausal women with moderate to severe hot flashes have been recruited into the trial The earliest effect of ultra low dose HRT hormone replacement therapy on frequency and severity of menopausal symptoms bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-000103-17 | EUDRACT_NUMBER | None | None |