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

09/03/2026
09/03/2026
EU PAS number:
EUPAS1000000606
Study
Planned
Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Other
Safety study (incl. comparative)

If ‘other’, further details on the scope of the study

PMS Study

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medicinal product name, other

Ovral-L (Levonorgestrel 0.15 mg and Ethinyloestradiol 0.03 mg)

Anatomical Therapeutic Chemical (ATC) code

(G03AA07) levonorgestrel and ethinylestradiol
levonorgestrel and ethinylestradiol

Medical condition to be studied

Dysmenorrhoea
Endometriosis
Abnormal uterine bleeding
Study design details

Study design

Surveillance study