Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Contraception in adolescents - regulatory considerations ***

Dr. Julian Paesler (Abschlußjahr: 2016)

Summary
Language: English
There is a relevant percentage of young sexually active adolescents for whom safe and effective contraceptives are needed. According to a guideline published by the German Society of Gynaecology and Obstetrics, there were approximately 1.5 million women between 14-19 years of age taking oral contraceptives (OCs) in Germany in 2010. Contraceptive measures other than OCs, like e.g. transdermal patches, intravaginal rings or implants, were used only by a minority of all women.
There is no specific guidance on evaluation of efficacy and safety in the adolescent population in the current official European guidance on the regulatory requirements for the registration of hormonal contraceptives, already issued in the year 2000. Some aspects covered in the guideline, like e.g. the need to investigate the influence of the new contraceptives on ovarian function and endogenous estrogen production, are, however, of special relevance for the adolescent population. Decreased endogenous estrogen levels as a consequence of ovarian suppression could lead to a decrease in bone mineral density. In adolescent girls and young women, potential detrimental effects on bone metabolism could reduce peak bone mass and increase the risk for fractures in later life.
The current work focused on hormonal contraceptives, other contraceptive options like e.g. copper Intra Uterine Devices or barrier methods have, however, also been briefly considered. Based on some representative examples, it was evaluated, if clinical data on efficacy and safety in postmenarcheal adolescent girls have been provided and assessed during Marketing Authorisation Applications and/or later in the “regulatory life-cycle”. For this reason, the information provided in the SmPCs of different contraceptives has been checked for relevant information on clinical studies performed in the paediatric population. When Public Assessment Reports were available, it was investigated if efficacy and safety in the paediatric population had been separately discussed and if any potential need for further investigation in clinical trials in adolescents had been addressed. Special obligations in the Paediatric Investigation - or Risk Management Plan to further investigate the use in postmenarcheal adolescent girls, e.g. in post-marketing studies after authorisation, have also been considered.
In some of the provided Public Assessment Reports, the use of contraceptives in adolescent girls was not discussed at all. In the assessed PDCO Opinions on Paediatric Investigation Plans, the decisions to grant a waiver or to demand or agree to defer clinical studies varied considerably, the same is true for the coverage of this topic in the Risk Management Plans.
In summary, for contraceptives, further efforts should be taken to harmonise the assessment of clinical data relevant to postmenarcheal girls and the respective information given in the SmPC and PL.
Pages: 68
Annex: 1, Pages: 1