Best Practices to Drive Time and Cost Savings for Contraceptives | Page 5

Dual-acting microbiocides that can prevent pregnancy and provide protection against

Figure 4.

Study Endpoints

infection are of particular interest, especially in areas where sexually transmitted
infections, including HIV, are of great concern. The empowerment of women to control
their own reproductive life through effective contraceptives that they can control also
underpins some of the development efforts. In relation to long-term compliance, the

PRIMARY ENDPOINTS
PREGNANCY

development of additional long-acting reversible options would help to eliminate the

OTHER POTENTIAL
ENDPOINTS

issues with daily administration associated with oral contraceptives.

INFECTION
ACCEPTABILITY

Study design and trial characteristics »
When planning a clinical trial for a contraceptive product, it is important to realize
that the type of product under investigation will determine the study design and
trial characteristics:

VAGINAL PRODUCTS:
Irritation and rash
HORMONAL PRODUCTS:
Spotting/Bleeding,
menstrual cycle
frequency, and duration

• While the primary endpoint of all contraception remains pregnancy, some
dual-acting methods will also require monitoring of endpoints relating to infection.
• Acceptability is another important outcome for all products, usually measured via questionnaires, but it is of particular importance
for some methods such as vaginal products where data should be collected regarding irritation, rash, and other side effects.

• Trials of hormonal products should also monitor spotting/bleeding
in addition to menstrual cycle frequency and duration.
• Monitoring of compliance is important in trials of products that
are used at the time of a sex act or administered daily or weekly,
while such monitoring is minimal or nonexistent with long-term
implantable devices.
• The side effects and risks associated with each product will also
differ and require different levels of monitoring and reporting.

Globally, nearly 600 clinical
trials are being conducted for
the development or validation
of contraceptive methods
in both men and women.8

• Different patient profiles and enrollment patterns can be
expected/based on the product characteristics.

clinipace.com

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