LEA contraceptivum

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Illustration of a lea contraceptivum

The LEA contraceptivum was through the company Yama Inc. in the United States developed and under the name Lea's Shield displaced barrier method of contraception for women. After FDA approval and market launch in 2002, production was relocated to Germany in 2009 , but discontinued in 2014 at the latest.

Manufacturers and distributors

The manufacturer of LEA contraceptivum was initially the developer Yama Inc. in Union City (New Jersey) , from 2009 the company BIOVISION GmbH from Ilmenau . The German sales partner was MEDISAVE Medical Products from Wiesbaden .
According to the Federal Center for Health Education , it was withdrawn from the German market in 2014. According to the MERKUR pharmacy in Nuremberg, the reason for this was the manufacturer's defective production machine.

application

LEA contraceptivum was inserted into the vagina, placed in front of the cervix, preventing the semen from entering the uterus .
In contrast to the diaphragm and cervical cap , the size and shape of the cervix did not matter, so there was only one size. The LEA sucked onto the cervix and supported itself on the back wall of the vagina.
Due to the biocompatibility of the material and the shape, it could remain in the vagina for over 48 hours, which on the one hand enabled a high degree of spontaneity. On the other hand, it was important for the safety of contraception that the LEA remains in the body for at least another 8 hours after the last sexual act, even if the wearing time of 48 hours was exceeded.

Contraceptive safety

The safety of contraception was controversial. The development company Yama Inc. commissioned studies on safety (exclusion of health risks), usability (user-friendliness or intuitive use) and contraceptive safety in the course of the approval process. These studies were carried out by external, independent organizations. The study on the safety of contraception was published in the journal Contraception . This contraceptive safety study was controversial due to the very small number of participants (182) and its short duration (6 months). There were no studies that were not commissioned by the development company.

The German distributor stated that the safety when used with spermicidal gel is 97.8 percent, citing the Yama study. These values ​​were also mentioned in pharmacies. Without the additional use of a spermicidal lubricant, however, the safety is lower (97.1%). The manufacturer and the German sales partner recommended barrier gels based on fruit or lactic acids. The use of spermicide gels containing nonoxynol-9 was also possible, but was not recommended due to the rare occurrence of intolerance.

The American Food and Drug Administration assumed a six-month pregnancy rate of 8.7% in women who used the lea contraceptive together with a spermicide (see link to the study that Yama submitted to the FDA). The Pearl Index was estimated at 15.
When used without a spermicide, the FDA estimated a six-month pregnancy rate of 16.6%.
The FDA did not have any other studies; it evaluated the existing study differently than the study authors. These extrapolated the individual groups of participants (childless or mothers, young or old) taking into account similar studies to the normal population and thus came to a safety of 97.8 percent or, in other words, a failure rate of 2.2 per six months.
The group of childless women who took part in the study was, however, very small, so that it was controversial whether this conversion led to representative statements.

In general, when comparing data on the Pearl Index, it is noticeable that the data from the FDA (see below) are more pessimistic than data from other authors.

The exact dates of the contraceptive safety study

  with spermicide gel without spermicide gel
Participant size 90 92
Nulliparous (childless) 17th 13
Parous (mothers) 73 79
Dropouts 31 45
Pregnancy at the start of studies 0 3
Violation of study conditions 9 10
personal reasons related to Lea 7th 6th
personal reasons unrelated to Lea 2 1
Medical reasons 1 2
Wanted pregnancy 1 0
Inability to use Lea 5 13
unplanned pregnancy 6th 10
Number of participants at the end 59 47
Number of people considered for evaluation 79 67

It was noticeable that none of the women who had never given birth became pregnant unintentionally. This resulted in a safety of 97.8% for the use of the LEA contraceptivum together with a spermicide (only including those users who used it correctly). It should be noted that this security is valid for a period of six months. In Germany, most contraceptives are stated to be safe for a period of twelve months.

Comparison of the safety of contraception with other contraceptives

Source:

Contraceptive method Pregnancy rate at 6 months Pregnancy rate after 12 months ( Pearl index )
surgical sterilization, intrauterine device, hormone injection, hormone implants smaller 1 smaller 1
Hormone pill, vaginal ring 1-2 1-2
condom 7th 12
Diaphragm 8th 17th
Cervical Cap 11 17th
Femidom 13 21st
Lea contraceptivum 8.7 15th

For the mechanical barrier contraceptives, six-month studies are usually carried out; the annual failure rate is calculated from the study data.

Individual evidence

  1. ↑ FDA approves Lea's Shield.
  2. ↑ Information from the MERKUR pharmacy in Nuremberg
  3. ↑ Information on the LEA contraceptivum
  4. ↑ Christine Mauck, Lucinda H. Glover, Eric Miller, Susan Allen, David F. Archer, Paul Blumenthal, Bruce A. Rosenzweig, Rosalie Dominik, Kim Sturgen, Jay Cooper, Fred Fingerhut, Lisa Peacock, Henry L. Gabelnick: Lea's Shield ®: A Study of the Safety and Efficacy of a New Vaginal Barrier Contraceptive Used With and Without Spermicide . Contraception 53 (1996), pp. 329-335, doi: 10.1016 / 0010-7824 (96) 00081-9
  5. ↑ lea-contraceptivum.de .
  6. ↑ a b c FDA: Summary of Safety and Effectiveness Data (PDF; 895 kB) Download on December 22, 2009.

Web links