An HCP survey-based active surveillance study to assess the safety of fixed dose combination of Levonorgestrel-Ethinyloestradiol (brand name Ovral-L) in the management of primary dysmenorrhea, endometriosis, and abnormal uterine bleeding among Indian females - Protocol# B6261001

Study identification

• EU PAS number:
  EUPAS1000000606
• Study ID:
  1000000606
• Official title and acronym:
  An HCP survey-based active surveillance study to assess the safety of fixed dose combination of Levonorgestrel-Ethinyloestradiol (brand name Ovral-L) in the management of primary dysmenorrhea, endometriosis, and abnormal uterine bleeding among Indian females - Protocol# B6261001
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  No information provided.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:15/06/2025

Actual:06/01/2025

Study start date

Planned:01/02/2026

Date of final study report

Planned:30/09/2026

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Protocol # B6261001