Biomedicine > Jadelle Implants > Research and Development


BIOMEDICINE

Jadelle® Implants: Research and Development

Jadelle contraceptive implants
Jadelle® implant

Why was Jadelle developed? 
The Population Council developed Jadelle to provide the same level of contraceptive protection as Norplant while using fewer implants, thereby making the method easier to insert and remove. 

Why are additional contraceptives needed? 
There is currently no reversible contraceptive that all women like and are able to use. A woman may try several methods until she finds the one that best suits her. Furthermore, a woman may switch methods several times during her reproductive lifetime because of changes in her age, health, economic security, marital status, lifestyle, and concept of ideal family size. All of these factors can have an impact on a woman’s decisions about contraception: when to use or stop using it, what kind to use, and when to switch to another method. Even with Jadelle as an option, there is a need for new contraceptives for groups of women whose needs are not met by available methods.

Where was Jadelle tested? 
Jadelle was studied in three multicenter trials beginning in 1990. The studies enrolled 1,393 rod users in seven countries. Almost half of the women studied were in the United States; other clinics were in Chile, the Dominican Republic, Egypt, Finland, Singapore, and Thailand. The studies provided data on blood levels, safety, and efficacy. The Council conducted clinical trials using an earlier version of the rods in five countries from 1983 to 1988
, which has since been reformulated. 

Much of the information regarding characteristics of levonorgestrel implants comes from extensive studies of the six-implant Norplant. In addition, many countries have conducted preintroduction studies to obtain data on local experience with the Norplant method and to train providers in insertion, removal, and counseling techniques. Norplant capsules have been used in clinical trials and preintroduction studies involving over 55,000 volunteers in more than 40 countries. 

Where has Jadelle been approved? 
Regulatory agencies in the following countries have approved Jadelle: Finland, France, Iceland, Indonesia, Luxembourg, Netherlands, Norway, Spain, Sweden, Thailand, and the United States. 
However, the implant is not currently available in all of the countries where it has received regulatory approval. It is not on the market, for example, in the United States. 

Is there a risk of Jadelle being used coercively? 
There is a risk of any provider-controlled method being used coercively. The Population Council strongly advocates the voluntary use of any contraceptive and believes that women have the right to balanced and accurate information, trained and capable health care providers, aseptic conditions, and ability to discontinue the use of the contraceptive on request. Wherever provider-dependent methods are offered, providers should obtain women’s informed consent at the time the method is adopted, and users should have ready access to removal of the rods by competent health care providers.

Return to Jadelle FAQ



Print this page

@
E-mail this page

This page updated
26 May 2005


 
What's New

Stay Informed
Sign up to receive e-mail alerts on this and other research areas.