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Brief Summary

GUIDELINE TITLE

Progestogen-only pills.

BIBLIOGRAPHIC SOURCE(S)

  • Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2009 Jun. 17 p. [44 references]

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2008 Nov. 17 p. [44 references]

2011 is the date of planned revision.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the Faculty of Sexual & Reproductive Healthcare (FSRH) and the National Guideline Clearinghouse (NGC): The print version of this Clinical Effectiveness Unit (CEU) Guidance Document (issued in November 2008) contained some inconsistencies that the CEU has corrected in the June 2009 version. These corrections are to the United Kingdom (UK) Medical Eligibility Criteria for Contraceptive use for progestogen-only pill (POP) use (page 1 and page 2, Table 2 in the original guideline document), advice for women who miss or are late taking POP (page 3, Figure 1 in the original guideline document), and recommendations for timing of initiation of POP (page 5, Table 3 in the original guideline document). The recommendations below are unchanged.

The recommendation grades (A to C, Good Practice Point) are defined at the end of the "Major Recommendations" field.

What Should a Clinician Assess before Progestogen-only Pill (POP) Use?

Health professionals should be familiar with the United Kingdom Medical Eligibility Criteria (UKMEC) for progestogen-only pills. (Good Practice Point)

Table: Definitions of UK Medical Eligibility Criteria for Contraceptive Use Categories

UKMEC Definition of Category
Category  
UKMEC 1 A condition for which there is no restriction for the use of the contraceptive method.
UKMEC 2 A condition for which the advantages of using the method generally outweigh the theoretical or proven risks.
UKMEC 3 A condition where the theoretical or proven risks usually outweigh the advantages of using the method.a
UKMEC 4 A condition which represents an unacceptable health risk if the contraceptive method is used.

aThe provision of a method to a woman with a condition given a UKMEC Category 3 requires expert clinical judgement and/or referral to a specialist contraceptive provider since use of the method is not usually recommended unless other methods are not available or not acceptable.

A clinical history should be taken to identify conditions given a UKMEC Category 3 or 4 for progestogen-only pill use. (Good Practice Point)

Blood pressure and an assessment of weight can be documented before starting a progestogen-only pill but this should be seen as part of a more general health check. (Good Practice Point)

What Information Should Be Given to Women Considering a POP?

Mode of Action

Women may be advised that traditional progestogen-only pills work by altering cervical mucus to prevent sperm penetration and for some women ovulation is also inhibited. (Grade C)

Women may be advised that the primary mode of action of the desogestrel-only pill is inhibition of ovulation. (Grade C)

Weight and Efficacy

Women may be advised that if used consistently and correctly all progestogen-only pills are more than 99% effective. (Grade C)

Women should be advised to take one progestogen-only pill at or around the same time every day and without a pill-free interval. (Grade C)

Women may be advised that there are no data to suggest that some progestogen-only pills are better at preventing pregnancy than others. (Grade B)

There is no evidence that the efficacy of progestogen-only pills (traditional or desogestrel-only) is reduced in women weighing >70 kilograms and therefore the licensed use of one pill per day is recommended. (Grade B)

Missed Pills and Efficacy

Women may be advised that if a traditional progestogen-only pill is more than 3 hours late or a desogestrel-only pill is more than 12 hours late they should:

  • Take the late or missed pill now
  • Continue pill taking as usual (this may mean taking two pills at the same time)
  • Use condoms or abstain from sex for 48 hours after the pill is taken. (Grade C)

Some women may consider that the desogestrel-only pill, with the 12-hour window, will improve pill taking and they should be supported in this choice. (Good Practice Point)

Vomiting (or Severe Diarrhoea) and Efficacy

If a woman vomits within 2 hours of pill taking another pill should be taken as soon as possible. (Grade C)

Drug Interactions and Efficacy

Women using liver enzyme-inducing medications short term should be advised to use condoms in addition to progestogen-only pills and for at least 4 weeks after the liver enzyme-inducer is stopped. (Grade C)

Women using liver enzyme-inducing medications long term should be advised that the efficacy of progestogen-only pills is reduced and an alternative contraceptive method should be considered. (Grade C)

Women may be advised that the efficacy of progestogen-only pills is not reduced by use of non-liver enzyme-inducing antibiotics and additional contraceptive protection is not required. (Grade C)

Return of Fertility

Women may be advised that there is no delay in return of fertility following discontinuation of a progestogen-only pill, and, therefore, if pregnancy is not desired then another effective method of contraception should be used. (Grade C)

Side Effects and Discontinuation

Women should be advised that changes in bleeding patterns with progestogen-only pill use are common: 2 in 10 women have no bleeding, 4 in 10 women have regular bleeding and 4 in 10 women have irregular bleeding. (Grade C)

Weight Change

Women may be advised that there is no evidence of a causal association between progestogen-only pill use and weight change. (Grade C)

Depression and Mood Change

Women should be advised that mood change can occur with progestogen-only pill use but, there is no evidence of a causal association for depression. (Grade C)

Headache

Women should be advised that there is no evidence of a causal association between the use of a progestogen-only pill and headache. (Good Practice Point)

Women of any age with a history of migraine (with or without aura) may safely use progestogen-only pills (UKMEC 1 or 2). (Grade C)

Women who develop new symptoms of migraine with aura while using progestogen-only pills should be advised to seek medical advice, as investigation may be appropriate. Continued use may be considered (UKMEC 3). (Grade C)

Cardiovascular Disease and Breast Cancer

There is no causal association between progestogen-only pill use and cardiovascular disease (myocardial infarction (MI), venous thromboembolism (VTE) and stroke) or breast cancer. (Grade B)

When Can POPs Be Safely Started?

Postpartum (Breast or Bottle Feeding)

Progestogen-only pills can be started up to and including Day 5 of the normal menstrual cycle to provide immediate contraceptive protection. If started after this time condoms or abstinence are advised for 48 hours. (Grade C)

Progestogen-only pills can be started up to and including Day 21 postpartum (no additional contraceptive protection is required). If started after this time condoms or abstinence are advised for 48 hours. (Grade C)

Following Abortion or Miscarriage

Progestogen-only pills can be started at the time of abortion or miscarriage (<24 weeks' gestation) or within 5 days. If started after this time condoms are required for the next 48 hours. (Grade C)

Ongoing Use of POPs and Follow Up

In the absence of special problems, women may be given up to 12 months' supply of progestogen-only pills at their first and follow-up visits. Follow up should be tailored to the individual woman, who should be advised to return at any time if problems arise. (Grade C)

Women may be advised that a progestogen-only pill can be continued until the age of 55 years when natural loss of fertility can be assumed. Alternatively they can continue using a POP and have follicle-stimulating hormone (FSH) concentrations checked on two occasions 1–2 months apart. If both FSH measurements are >30 IU/l this is suggestive of ovarian failure and they may continue with a progestogen-only pill or barrier contraception for one further year (or 2 years if aged <50 years). (Good Practice Point)

Managing Bleeding Problems in Women Using a Progestogen-Only Pill

Women who have a change in bleeding pattern when using a progestogen-only pill need to be assessed and the risk of sexually transmitted infections, pregnancy or gynaecological pathology considered. (Good Practice Point)

There is no evidence that changing the type and dose of progestogen will improve bleeding, but this may help some individuals. If, after exclusion of other causes, bleeding patterns are still unacceptable then an alternative contraceptive method may need to be considered. (Good Practice Point)

Definitions:

Grades of Recommendations

A: Evidence based on randomised controlled trials (RCTs)

B: Evidence based on other robust experimental or observational studies

C: Evidence is limited but the advice relies on expert opinion and has the endorsement of respected authorities

Good Practice Point: Where no evidence exists but where best practice is based on the clinical experience of the multidisciplinary group

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations" field).

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2009 Jun. 17 p. [44 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2008 Nov (revised 2009 Jun)

GUIDELINE DEVELOPER(S)

Faculty of Sexual and Reproductive Healthcare - Professional Association

SOURCE(S) OF FUNDING

Faculty of Sexual and Reproductive Healthcare

GUIDELINE COMMITTEE

Clinical Effectiveness Unit

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Clinical Effectiveness Unit (CEU): Dr Susan Brechin (Unit Director); Ms Lisa Allerton (Unit Researcher); Dr Madhuri Thakur (Former Unit Researcher)

Clinical Effectiveness Committee: Mrs Doreen Bell (Public Partner QIS Scotland/User Representative); Dr Amanda Britton (Lead in Contraception and Sexual Health – Hampshire Primary Care Trust (North and East)/General Training Committee Representative FRSH, CASH, Basingstoke, UK); Dr Jagruti Doshi (Subspeciality Trainee in Sexual and Reproductive Health/Clinical Standards Committee Representative FSRH, Margaret Pyke Centre, London, UK); Dr Tamsin Groom (Consultant in Sexual and Reproductive Health); Dr Kate Guthrie (Consultant in Sexual and Reproductive Health, Conifer House, Hull, UK); Dr Noel Mack (General Practitioner, Kemnay Medical Group, Kemnay, Aberdeenshire,UK); Dr Pauline McGough (Consultant in Sexual and Reproductive Health, Sandyford Initiative, Glasgow, UK); Ms Shelley Mehigan (Nurse Specialist in Contraception/Clinical Effectiveness Committee Representative FSRH, The Garden Clinic, Sexual Health Services, Upton Hospital, Slough, UK); Dr Radhika Shah (General Practitioner, Camden and Islington, London, UK with a special interest in reproductive health, and Clinical Medical Officer, Brook Young Persons Advisory Services/Education Committee Representative FSRH); Mrs Anne Simpson (Public Partner QIS Scotland/User Representative); Dr Anne Webb (Consultant in Sexual and Reproductive Healthcare, Abacus Clinics for Contraception and Sexual Health, Liverpool Primary Care Trust, UK). Written feedback was received from: Dr Alyson Elliman (Consultant in Sexual and Reproductive Health Care, Croydon Primary Care Trust, Croydon, UK); the FSRH Clinical Effectiveness Committee and two independent reviewers: Professor Ian Fraser (Professor of Reproductive Medicine, The Queen Elizabeth II Research Institute for Mothers and Infants, The University of Sydney, Sydney, Australia) and Professor Pier Georgio Crosignani (Director, Institute of Obstetrics and Gynaecology, Ospedale Maggiore Policinico, Mangiagalli e Regnia Elena, Milan, Italy)

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

None

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit. Progestogen-only pills. London (UK): Faculty of Sexual and Reproductive Healthcare; 2008 Nov. 17 p. [44 references]

2011 is the date of planned revision.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the Faculty of Sexual and Reproductive Health Care Web site.

Print copies: Available from the Faculty of Sexual and Reproductive Health Care, 27 Sussex Place, Regent's Park, London NW1 4RG

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on July 13, 2009. The information was verified by the guideline developer on August 18, 2009.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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