CONTENTS
Chapters
- Research and Regulatory Approval
- Use of Injectables
- Effectiveness and Reversibility
- Side Effects and Complications
- More Evidence in the Cancer Debate
- Noncontraceptive Health Benefits
- Counseling Issues
- Communicating with the Public
- Maximizing Access and Quality
Published with this issue:
HIGHLIGHTS
Published by the Population Information Program, Center for Communication
Programs, The Johns Hopkins School of Public Health, 111 Market Place, Suite 310, Baltimore,
Maryland
21202-4012, USA
Volume XXIII, Number 2
August 1995 |
Monthly injectables have been most widely used in China and Latin America. Chinese
Injectable Number 1 consists of hydroxyprogesterone caproate and
estradiol valerate and has been used by about 1 million women (271). In
Latin America at least one million women use dihydroxyprogesterone acetophenide
and estradiol enanthate, which was originally developed by Squibb Pharmaceutical
Company in the 1960s and marketed under the brand name Deladroxate.
Within a few years Squibb withdrew Deladroxate, but the same formulation,
manufactured by others, is now marketed in Latin America and Spain under
a variety of other brand names (see Table
1). It has not been thoroughly studied (223,
331).
Two new monthly injectables, Cyclofem and Mesigyna, have
completed multinational clinical trials conducted by WHO. They
are being introduced in a number of countries.
- Cyclofem, previously known as Cycloprovera, combines
DMPA and the estrogen estradiol cypionate. The Upjohn
Company developed Cycloprovera and turned it over to
WHO in 1984.
- Mesigyna, developed by WHO, combines NET EN and the
estrogen estradiol valerate.
Introductory trials of Cyclofem have been conducted in
Chile, Indonesia, Jamaica, Mexico, Thailand, and Tunisia, and the
new injectable has been registered in Guatemala, Indonesia,
Mexico, Peru, and Thailand. The Concept Foundation, a private
nonprofit organization set up by the Program for Appropriate
Technology in Health (PATH) and given rights to Cyclofem by WHO,
has licensed manufacturers in Indonesia and Mexico to produce
Cyclofem and has identified distributors in other countries,
primarily in Latin America. The Upjohn Company has obtained
rights to Cyclofem in the US and in several other developed and
developing countries. Upjohn plans to submit an application for
Cyclofem to the US FDA by August 1996 (318).
Schering AG is handling registration, distribution, and
marketing of Mesigyna. Schering AG plans to begin marketing
Mesigyna in Latin America. Mesigyna is manufactured in Mexico
and
has been registered in Argentina and Brazil as well as Mexico (74).
With new opportunities to offer injectables, policymakers, program managers,
and providers need to reacquaint themselves with these contraceptives:
their effectiveness and reversibility, side effects, and noncontraceptive
benefits, why women use injectables, and how users respond to side effects.
This knowledge can help program staff make decisions concerning communication
and service delivery issues posed by injectables (see "Lessons
Learned" of "DMPA at a Glance").
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