Introduction of cyclofem once-a-month injectable contraceptive in Mexico

Area of Science:

• Reproductive Health
• Contraception
• Clinical Trials

Background:

• Cyclofem is a once-a-month injectable contraceptive.
• Introduction of new contraceptive methods requires rigorous safety and effectiveness studies.

Purpose of the Study:

• To evaluate the use-effectiveness and safety of Cyclofem under routine family planning conditions in Mexico.
• To assess user continuation rates and reasons for discontinuation.

Main Methods:

• A large-scale, prospective introductory study involving 3457 healthy women in three Mexican provinces.
• Data collected over 20,316 women-months of treatment experience.
• Comparison of community-based versus health center-based service delivery components.

Main Results:

• Cyclofem exhibited high use-effectiveness with a pregnancy rate of 0.03%.
• Overall 1-year continuation rate was 26.1%, with higher rates in community settings (36.6%) versus health centers (23.7%).
• Method discontinuation due to side effects was low (<11% for bleeding problems).

Conclusions:

• Cyclofem is a safe and highly effective injectable contraceptive method for routine family planning.
• Service delivery factors, including counseling and accessibility, significantly impact continuation rates.
• Study results supported Cyclofem's approval and integration into Mexico's national family planning program.