1. Hormonal Contraception & Factors Affecting Effectiveness
Jan Bowden

2. Aims of the session Define Bleeding terms.
Explore what effects the effectiveness of the combined oral contraceptive pill (CoC).
Identify best practice

3. The Hormonal Methods (HMs)
There are many other effects of the HMs apart from the obvious contraceptive benefits.
The common side effects many be positive ones or negative ones depending on the symptoms and how that affects the client
Break through bleeding (BTB) is the most common and irritating for client and practitioner.
More common with the combined methods and the POIs

4. Expected Bleeding Patterns
Method
1st 3 months
Long term
CHC
20% have irregular bleeding
Usual settles after 1st 3 months. CVR may offer better cycle control. Report less bleeding with use
POP
Unpredictable
1/3 with traditional POP have a change in pattern. ?? More common in DSG users
May not settle with time
DSG 5 in 10 can expect amenorrhoeic or infrequent bleeding
POI
Heavy disturbance in 1st 3 months
2 in 10 will be amenorrhoeic
SDI
Common in 1st 3 months
90% reduction in blood loss over 1 yr (Mirena)

5. Bleeding patterns
Clients should be strongly advised about the bleeding pattern they might expect when starting hormonal contraception- both short and long term.
A thorough clinical assessment should be taken when problematic bleeding is identified to attempt to identify an underlying cause.

6. Those with a STI risk should be offered testing for Chlamydia & Gonorrhoea.
If eligible but not participant they should be offered a smear BUT this is not for diagnosis.
If history indicates a pregnancy test might be offered.
An examination is not necessary IF clinical history indicates no risk for STIs, no concurrent symptoms suggesting a course and have had no more than 3 months of bleeding since starting the method

7. Speculum Examination Speculum examination may be undertaken if:
Persistent bleeding or change in bleeding pattern after 3 months of use.
If medical treatment has failed.
If no participation in smear screening.
A biopsy should be considered if client is over 45 or under 45 with risk factors of endometrial cancer.

8. Break Through Bleeding:
BTB is the most common reason for stopping the CoC.
Up to 20% have irregular bleeding in 1st 3/12.
Often CoC users will stop without consultation and run the risk of an unwanted pregnancy
Defines as unscheduled bleeding in women using CHC

9. How do you define these terms?
Clinically important bleeding patterns in women aged 15–44 years
SCHEDULED BLEEDING
Menstruation or regular withdrawal bleeding with combined hormonal contraception (requiring sanitary protection)
UNSCHEDULED BLEEDING
Frequent
Infrequent
Prolonged
Spotting
How do you define these terms?
Reference period: a 90 day period of time during the use of a hormonal method

10. Frequent
Prolonged
Infrequent
Spotting

11. It is important to bear in mind the
following:
Do not simply change the brand of CoC she is currently using.
Assess for other causes of BTB first.
Give reassurance and information as the client may have concerns regarding, if the CoC is working properly, if she is pregnant, if she has cancer, if she has an infection.

12. Pregnancy Risk and BTB
Break through bleeding provided the CoC is being taken properly should not lead to unwanted/unplanned pregnancy.
A careful history is necessary to elicit pill taking as well as a careful medical assessment of current health and past health.

13. What are the causes of breakthrough bleeding ?
DON’T PEAK……..
What are the causes of breakthrough bleeding ?

14. The main causes of BTB: This can be remembered as the 9 Ds: Default.
Duration.
Diarrhoea & vomiting.
Disturbance of absorption.
Dose
Diet.
Disease.
Drugs.
Disorders of pregnancy.

15. Duration.
In general, continue with the same pill for at least 3 months as bleeding may settle in this time.
Use a COC with a dose of EE to provide the best cycle control.
May consider increasing the EE dose up to a maximum of 35mcg
May try a different COC but no evidence one better than any other in terms of cycle control.
No evidence changing progestogen dose or type improves cycle control but may help on an individual basis.

16. Drugs. 1. Pharmacokinetics 2. Pharmacodynamics
Serum levels of contraceptive hormones may be increased or decreased by concomitant drug use and hormonal contraceptives may themselves increase or decrease serum levels of other drugs used at the same time .
Therefore drug interactions should be considered when prescribing medication for women who may use hormonal contraception and could be at risk of contraceptive failure or other adverse effects.
1. Pharmacokinetics
2. Pharmacodynamics

17. 1. Pharmacokinetics
interactions occur when one drug alters the absorption,distribution, metabolism or excretion of another, thereby increasing or decreasing its serum concentration and its effects.
The anti-obesity drug orlistat (Xenical®), also available over the counter as Alli®, may theoretically affect absorption of oral contraceptives by inducing diarrhoea, that has the potential to reduce contraceptive efficacy and advises additional precautions in those with severe diarrhoea.
Concomitant medication may also induce vomiting. Women who vomit within 2 hours of taking an oral contraceptive should repeat the dose as soon as possible.
The general advice for women using oral contraceptives who have persistent vomiting or severe diarrhoea for more than 24 hours is to follow the instructions for missed pills.

18. 2. Pharmacodynamics
interactions occur when one drug directly influences the clinical actions of another by synergy or antagonism.
For example, contraceptive steroids might reduce the efficacy of antihypertensives, lipid-lowering drugs and antidiabetics because they can have opposing actions.

19. Enzyme Induction Affects both oestrogen & progestogens.
Takes place in the liver.
Certain drugs increase the synthesis of enzymes.
Most clinically significant of the 2 mechanisms.
Most likely to cause pill failure and pregnancy.
Liver enzyme inducing drugs need special pill rules or non hormonal method

20. Gut wall metabolism & reduced entero-hepatic circulation
Affects oestrogen only.
Some drugs (particularly antibiotics e.g Rifampicin) kill natural flora in the gut.
These flora help with gut wall metabolism allowing drugs i.e. oestrogen to be absorbed.
They also assist in the recirculation of conjugated oestrogens after they have passed through the liver.

21. Best practice
Health professionals supplying hormonal contraception should ask women about their current and previous drug use including prescription, over the counter, herbal, recreational drugs and dietary supplements.
Women using hormonal contraception should be informed about the potential for interactions with other drugs and the need to seek the advice of a health professional before starting any new drugs.

22. Enzyme-inducing drugs
Enzyme –inducing drugs may increase metabolism of EE &/or progestogen.
This can decrease bioavailability and potentially reduce the contraceptive benefit of the COC.
Commonly used enzyme-inducing drugs include: some antiepileptics inc Carbamazepine & Phenytoin, Antibiotics such as Rifampicin, Antiretroviral Ritonavir, EC ellaOne, Antacids, St John’s Wort

23. Best Practice
All women starting enzyme-inducing drugs should be advised to use a reliable contraceptive method unaffected by enzyme inducers (e.g. progestogen-only injectable, Cu-IUD or LNGIUS).
Women who do not wish to change from a combined method while on short-term treatment with an enzyme-inducing drug (and for 28 days after stopping treatment) may opt to continue using a COC containing at least 30 μg EE, the patch or ring together with additional contraception.
An extended or tricycling regimen should be used with a hormone-free interval of 4 days.
Additional contraception should be continued for 28 days after stopping the enzyme-inducing drug.

24. Best Practice
Women who do not wish to change from the progestogen-only pill or implant while on short term treatment with an enzyme-inducing drug or within 28 days of stopping treatment may opt to continue the method together with additional contraceptive precautions (e.g. condoms). Additional precautions should be continued for 28 days after stopping the
enzyme-inducing drug.
Women using enzyme-inducing drugs who require EC should be advised of the potential interactions with oral methods and should be offered a Cu-IUD.

25. Emergency Contraception
Women who request oral EC while using enzyme- inducing drugs or within 28 days of stopping them should be advised to take a total of 3 mg LNG (two 1.5 mg tablets) as a single dose as soon as possible and within 120 hours of UPSI (use of LNG >72 hours after UPSI and double dose are outside the product licence).
Ulipristal acetate is not advised in women using enzyme-inducing drugs or who have stopped
them within the last 28 days.

26. Points to cover in history taking when assessing unscheduled bleeding.......
Woman’s concerns
Current method of contraception and the duration of use
Use of the current contraceptive method
Use of medications (including over-the- counter preparations) that may interact with the contraceptive method, or any illness that may affect the absorption of orally administered hormones
Cervical screening history
Risk of sexual transmitted infections (i.e. for those aged <25
years, or at any age with a new partner, or more than one partner in the last year)
Bleeding pattern before starting hormonal contraception since starting and currently

27. Any other symptoms suggestive of an underlying cause (e.g.
abdominal or pelvic pain, postcoital bleeding, dyspareunia, heavy bleeding)
The possibility of pregnancy

28. BTB of unknown cause
If , after full counselling, full assessment and investigation, the client is happy to continue will the CoC this is acceptable.
Even the strongest & most progestogen dominant pill will not be sufficient endometrial stability in some women.

29. USEFUL SOURCES OF INFORMATION ABOUT DRUG INTERACTIONS tm