Ignite Creation Date:
2024-05-05 @ 10:58 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01221831
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2010-10-13
Brief Title:
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
Sponsor:
Estetra
Organization:
Estetra
Study Overview
Official Title:
A Randomised Open-label Multi-centre Comparative Study to Evaluate Cycle Control of 2 Dosages of Estetrol Combined With Either P1 or P2 Compared to a Combined Oral Contraceptive Containing E2V and DNG
Status:
COMPLETED
Status Verified Date:
2012-09
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:
FIESTA
Brief Summary:
This is an open-label multi-centre comparative study in young healthy female volunteers of reproductive age
Primary objective
- To investigate the effect of 2 dosages of estetrol combined with P1 or P2 on vaginal bleeding patterns cycle control in comparison with a combined oral contraceptive containing estradiol valerate and dienogest
Secondary objectives
To investigate ovulation inhibition
To investigate the effect on SHBG
To assess pregnancy rate
To evaluate subject satisfaction dysmenorrhoea acne and body weight
To investigate return of menstruation after treatment
To evaluate general safety and acceptability
Primary objective
- To investigate the effect of 2 dosages of estetrol combined with P1 or P2 on vaginal bleeding patterns cycle control in comparison with a combined oral contraceptive containing estradiol valerate and dienogest
Secondary objectives
To investigate ovulation inhibition
To investigate the effect on SHBG
To assess pregnancy rate
To evaluate subject satisfaction dysmenorrhoea acne and body weight
To investigate return of menstruation after treatment
To evaluate general safety and acceptability
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 |
|---|---|---|---|
| 2010-019865-26 | EUDRACT_NUMBER | None | None |