What to expect

Product information and a link to the SPC is available at the bottom of the page.

What can women expect with Depo-Provera? To help manage their expectations, there are several important things to know.

Women should be counselled that there is a potential for delay in return to ovulation following use of the method, regardless of the duration of use.1*

Clinical trials studied the mean time to return to ovulation up to 15 months following the last dose of DMPA-IM:1

 
 Pregnancies have occurred as early as 14 weeks, post-injection

*Repeat injections are required every 12 weeks (± 5 days) to maintain and ensure efficacy1

 


 

After the first injection of Depo-Provera, it is likely that women will experience some changes to their menstrual cycle.1
Amenorrhoea data were analysed from contraception studies of 1-year treatment with depot medroxyprogesterone acetate intramuscular (DMPA-IM)1
Women should be advised that there is the potential for:1
-  Irregular bleeding and spotting
-  Prolonged episodes of bleeding (> 10 days)*
-  Rarely, heavy prolonged bleeding.
Up to 30% of women will stop having 'periods' during the first 3 months and the percentage of women with amenorrhoea increases with time.1
*After the first injection, up to 33% of women may have prolonged episodes of bleeding; in 12% of women this may still be occurring after a year. Rarely, heavy prolonged bleeding may occur.

 

See below for a diagrammatic representation of the proportion of women who experienced amenorrhoea during 1-year treatment with DMPA-IM1

 

Weight change data were analysed from DMPA-IM contraception studies:1
-  Over first 1-2 years of use – average weight gain was 2.3-3.6 kg (5-8 lbs)
-  Women completing 4-6 years of therapy – gained an average of 6.4-7.5kg (14-16.5lbs)
-  There is evidence that weight is gained as a result of increased fat and is not secondary to an anabolic effect or fluid retention1

 

Use of depot MPA subcutaneous injection reduces serum estrogen levels and is associated with significant loss of BMD due to the known effect of estrogen deficiency on the bone remodelling system. Bone loss is greater with increasing duration of use, however BMD appears to increase after DMPA subcutaneous injection is discontinued and ovarian estrogen production increases.

This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of DMPA subcutaneous injection by younger women will reduce peak bone mass and increase the risk for fracture in later life.

A randomised, evaluator-blinded, Phase III, 2-year study found DMPA-SC to have a comparable BMD side effect profile to DMPA-IM.2

  • DMPA-SC changes in BMD are reversible after stopping treatment.1
  • Concerns regarding BMD must be considered against the potential contraceptive benefits of DMPA-SC for each individual user, and treatment must be re-evaluated every 2-years.1
  • As adolescence is an important time of bone accretion, DMPA-SC may be used, but only after other methods of contraception have been discussed with the patient and considered unsuitable or unacceptable.1

Consider baseline risk factors for osteoporosis before prescribing DMPA-SC.1

  • Alcohol abuse
  • Smoking
  • Chronic use of medicines that can reduce bone mass
  • Osteoporosis family history
  • Low trauma fracture
  • Low body mass index or an eating disorder

A long-term case-controlled surveillance of Depo-Provera users has shown that:1
-  Use of Depo-Provera does not increase risk of ovarian, liver, or cervical cancer
-  There was a prolonged, protective effect of reducing the risk of endometrial cancer with DMPA-IM users.

Some epidemiological studies suggest a small difference in risk of breast cancer in current and recent users. It showed:1
-  Any excess risk in current or recent users is small in relation to the overall risk of breast cancer, particularly in young women
-  The risk is not apparent after 10 years since last use
-  Duration of use does not seem to be important.

Women should be counselled that Depo-Provera does not protect against sexually transmitted infections (STIs) including HIV infection (AIDS). Safer sex practices including correct and consistent use of condoms reduce the transmission of STIs through sexual contact, including HIV. 

HIV: Human Immunodeficiency Virus
AIDS: Acquired Immunodeficiency syndrome

Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment. Reports of anaphylaxis have been received.2

For a list of all adverse events refer to the SPC.

References

1. Depo-Provera Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/11121 Accessed February 2019
2. https://www.medicines.org.uk/emc/product/3148/smpc

Summary of Product Characteristics:

Depo-Provera
Legal Category: POM  Basic NHS Price : £6.01

 

PP-DEP-GBR-0054.  May 2020