MANUSCRIPT 1

Promoting family planning

Contraceptive technology

Safety and efficacy of existing methods

The Department’s research arm is the UNDP/ UNFPA/WHO/World

Bank Special Programme of Research, Development and Research
Training in Human Reproduction (HRP).
Most of the information on the safety and clinical performance of
methods of fertility regulation is generated in developed countries
and may not apply to developing country populations. In addition,
before registration, products are tested among carefully screened
volunteers and their safety and effectiveness need to be assessed
under actual conditions of use. Through its research, HRP fills these
gaps in knowledge and produces evidence which informs the
guidelines and training materials that the Department produces on
fertility regulation methods.

Implantable contraceptives
HRP is supporting a randomized comparative study of two
implantable contraceptives, Jadelle and Implanon. Jadelle,
developed by the Population Council, consists of two rods that
release levonorgestrel; Implanon is a single-rod system delivering
etonorgestrel. The study is being conducted in seven countries, and
a total of 2000 women have been randomly allocated to receive one
of the two implants. In parallel, an age-matched cohort of 1000
women who have chosen the TCu-380A intrauterine device (IUD) is
being followed as control for non-reproductive system complaints.
The study is designed to evaluate pregnancy rates, incidence of
adverse effects, continuation rates, and reasons for discontinuation
over five years. It will also provide safety and efficacy data for
Implanon beyond three years of use.
Progestogen-only contraceptives and bone health
Over 20 million women are currently using progestogen-only
contraceptives, including oral preparations, injectables [depot-
medroxyprogesterone acetate (DMPA) and norethisterone enantate
(NETEN)], implants, vaginal rings, and the levonorgestrel-releasing
IUD. Concerns have been expressed that use of these methods can
lead to loss of bone mineral density, and thus increased risk of
osteoporotic fracture. A study in Durban, South Africa, has
investigated the impact of use of such contraceptives on women
aged 15–19 years, when acquisition of bone mass is maximal, and
42–49 years, entering menopause. A total of 986 women were
followed every six months for five years. In the older group, there
was little difference between the groups using DMPA, NET-EN, or
combined oral contraceptives and controls. However, there was a
clear trend of increasing bone mineral density and body mass index
with increasing age. In the younger group, a similar increase in bone
mineral density was seen in those using DMPA or combined oral
contraceptives and in controls. The increase was smaller among
those using NET-EN. Recovery of bone mineral density in NET-EN
users was found in the small sample of adolescents followed post-
discontinuation.
PUBLICATIONS:

Beksinska ME, Smit JA, Kleinschmidt I, Farley TMM, Mbatha F. Bone

mineral density in women aged 40–49 years using depot-
medroxyprogesterone acetate, norethisterone enanthate or
combined oral contraceptives for contraception.Contraception 2005;
71:170-175.
Beksinska ME, Kleinschmidt I, Smit JA, Farley TMM. Bone mineral
density in adolescents using norethisterone enanthate, depot-
medroxyprogesterone acetate or combined oral contraceptives for
contraception. Contraception 2007; 75(6):438-43.
Beksinska ME, Kleinschmidt I, Smit JA, Farley TMM. Bone mineral
density in a cohort of adolescents during use of norethisterone
enanthate, depot-medroxyprogesterone acetate or combined oral
contraceptives and after discontinuation of norethisterone
enanthate. Contraception 2009; Volume 79, Issue 5, Pages 345-349.
RELATED DOCUMENTS

• Provider brief
pdf, 371kb
2 pages, 2007
• Report of a technical consultation
Technical consultation on the effects of hormonal
contraception on bone health, June 2005
• WHO statement on hormonal contraception and bone
Weekly epidemiological record, No. 35, 2005, 80, 297–304.

Hormonal contraception in women with HIV infection

A multicentre study in Kenya, Thailand and Zimbabwe assessed the
impact of different contraceptive methods on the clinical course of
HIV infection. The study enrolled women with early stage disease
and using combined oral contraceptives, progestogen-only
injectables, or non-hormonal methods of contraception; follow-up
was for a maximum of four years, to determine disease progression,
the incidence of opportunistic infections, and changes in CD4+ cell
count and viral load. Preliminary results do not suggest that there
are large differences in disease progression according to type of
contraceptive method used. There is no reason to advise women
with HIV infection to avoid use of hormonal contraception. A
manuscript summarizing the findings will be submitted for
publication in 2009.
RELATED DOCUMENT

• Statement
pdf, 81kb
Hormonal Contraception and HIV: Science and Policy - Africa
Regional Meeting, Nairobi 19-21 September 2005.
• French
pdf, 69kb
• Portuguese
pdf, 82kb
• Spanish
pdf, 90kb
No association between vasectomy and prostate cancer
In response to mixed results from previous studies of a possible
relationship between vasectomy and prostate cancer, HRP
supported a hospital-based case-control study in China, Nepal and
the Republic of Korea to evaluate the risk of prostate cancer after
vasectomy. The study included 294 cases of prostate cancer and
879 matched controls. Study results revealed no association
between vasectomy and prostate cancer in these settings, where
the rate of the disease is low.
PUBLICATION:

Schwingl PJ, Meirik O, Kapp N, Farley TM. Prostate cancer and

vasectomy: a hospital-based case-control in China, Nepal and the
Republic of Korea.Contraception (2009) 79:363-368.
Hormonal contraception and risk of STI acquisition
There are many factors that increase the chance of developing an
STI. The most common ones are: having multiple sexual partners,
having sexual intercourse with partners who have more than one
sexual partner, not using condoms during intercourse, the presence
of genital ulcer disease, young age, and previously having had an
STI. What is not established is whether a woman’s use of hormonal
contraceptives may increase her risk of developing an STI.
A WHO Expert Working Group reviewed studies carried out to date
and their findings to determine whether women at risk for STIs
should use hormonal contraceptive methods. After extensive
review, the Working Group determined that there should be no
restriction of use for any of the hormonal contraceptives for any
woman based on her estimated risk of acquiring an STI..
RELATED DOCUMENT:

• English
pdf, 51kb
Provider brief
 • French
pdf, 78kb
Note d'information
• Spanish
pdf, 58kb
Nota de información

MANUSCRIPT 2

Oral Contraceptive Use and Mortality, Setting the Record Straight

The long-term health effects of oral contraceptive use have been the focus of research,
discussion and debate for quite some time.

Oral contraceptives have a long history. In the United States, they became available to women
in the early 1960s, and due to their convenience and effectiveness they have become the most
popular form of birth control in the country. However, questions have been raised concerning
the role that the hormones in oral contraceptives play in the development of some cancers.

Some clarity to these questions was recently provided by findings from a large cohort
study published in the March 11 issue of the British Medical Journal. The findings from
the Royal College of General Practitioners’ Oral Contraception Study suggest that oral
contraceptive use is not associated with increased long-term mortality rates.

“Early reports from the study indicated an increased risk of death among ever-users of these
contraceptives, mainly because of an excess of vascular events among older users or those
who smoked,” the study authors wrote. They added, “A later report, based on up to 25 years of
follow-up, suggested that most of the mortality effects of oral contraceptives occurred in
current or recent users, with few effects persisting beyond 10 years after stopping use.”

The study began in 1968 and examines mortality data from 1400 general practices throughout
the United Kingdom and National Health Service central registries to determine if the mortality
risk among women who have used oral contraceptives is different from women who have not
used them. The study observed 46,112 women for up to 39 years, which resulted in 378,006
“woman-years of observation” among those who used oral contraceptives and those who have
not.

During the period of observation, “ever-users” of oral contraception had a significantly lower
rate of “all-cause mortality,” compared with “never-users.” Mortality rates from all cancers and
all other diseases were also significantly lower in ever-users compared with never-users.
Although an association between overall mortality rate and duration of oral contraceptive use
was not observed, some disease-specific associations were seen. For instance, women younger
than 45 who had stopped using oral contraceptives five to nine years had an increased relative
risk for death from any cause, but those who had stopped use longer did not.

The study authors concluded that the “[p]erception about the safety of oral contraception
depend on whether current, recent, or more distant use of oral contraception is being
assessed.” They added, “The balance of risks and benefits, however, may vary around the
world, depending on patterns of oral contraception usage and the prevalence of difference
diseases.”

Clearly, the discussion is not over yet. However, these findings are encouraging for those who
are aiming to increase the use of family planning and improve maternal and child health
worldwide. In order to support the discussion and to ensure that health practitioners have the
information they need to make informed decisions, the Knowledge for Health project
(K4Health) in partnership with a number of organizations have developed various eToolkits
around topics related to family planning. K4Health is also developing an eToolkit specifically on
oral contraception that will be published in the near future, so stay tuned.

REFERENCE: Chris Rottler, Senior Communication Manager