Condition category
Pregnancy and Childbirth
Date applied
12/05/2008
Date assigned
31/07/2008
Last edited
04/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Judith Stephenson

ORCID ID

Contact details

Research Unit
Margaret Pyke Centre
73 Charlotte Street
London
W1T 4PL
United Kingdom
+44 (0)20 7530 3619

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MPC 134

Study information

Scientific title

Acronym

Study hypothesis

High rates of unintended pregnancy and abortion in the United Kingdom (UK) are a major public health issue, with over 180,000 abortions each year. The psychological, social and economic costs of unintended pregnancy and abortion exert a heavy toll on service users and the NHS.

Combined oral contraception ('the pill') is a highly effective and safe contraceptive method, but between a third and two thirds of women who do not wish to become pregnant will stop the pill after one year, and one of the chief reasons for this is irregular bleeding. Standard use entails taking the pill daily for 21 days, followed by 7 pill-free days when a monthly withdrawal bleed occurs. Many women wish to have fewer periods and the monthly withdrawal bleed with standard pill use can be prevented by simply leaving out the pill-free days. This seems to cause fewer menstrual symptoms (e.g. headache, breast tenderness, bloating) but more irregular bleeding.

Another option is 'tailored' pill use, where a woman takes the pill daily until bleeding triggers a pill-free interval. The withdrawal bleed that occurs in the pill-free interval seems to discourage further irregular bleeding when the pill is restarted, leading to the desired combination of fewer withdrawal bleeds and less irregular bleeding. If true, tailored use should lead to more women staying on the pill and fewer unintended pregnancies.

We propose a randomised controlled trial (RCT) to find out whether tailored pill use is better than standard pill use by seeing which approach leads to more women staying on the pill for at least a year. We will seek consent from 500 women aged 18 - 45 years attending sexual health services to be randomly allocated to standard or tailored pill use. We will follow them for 12 months and compare results between women taking the pill in the two different ways. The results of the trial will show the best way of taking the pill to help women continue with the pill, minimise unwanted effects and reduce unintended pregnancies in the UK.

Ethics approval

Ethics approval received from the Royal Free Hospital and Medical School Research Ethics Committee on the 9th January 2008 (ref: 07/H0720/180).

Study design

A multi-centre, randomised, open, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet

Condition

Unintended pregnancy and abortion

Intervention

Standard group:
Microgynon 30 (one pill a day taken orally for 21 days followed by a 7-day pill free interval).

Tailored group:
Microgynon 30, taken orally, continuously (one pill a day) with a 3-day pill free interval triggered by bleeding per vagina for a minimum of 3 consecutive days, which requires the use of sanitary protection on each day. Following the pill free interval, the pill needs to be taken for a minimum of 21 days (3 weeks) before another pill free interval can be taken, triggered by bleeding per vagina for a minimum of 3 consecutive days requiring the use of sanitary protection.

These two groups will take the pill in the allocated way for 12 months. Each woman (regardless of treatment group) will be followed up for 12 months from the time of randomisation (baseline visit); first follow up will be at 3 months after starting on the pill, second follow up will be 6 months after the first follow up visit (at 9 months). Women will be completeing regularly an on-line diary during this time and at 12 months, women will be invited to complete an end of study on-line questionnaire.

Please use the following contact details to request a patient information sheet:
Heidi Chandler
Study Co-ordinator
UK Clinical Research Network in Sexual & Reproductive Health
Research Unit
Margaret Pyke Centre
73 Charlotte Street
London W1T 4PL
Email: hchandler@gum.ucl.ac.uk

Intervention type

Drug

Phase

Not Specified

Drug names

Combined oral contraceptive

Primary outcome measures

Adherence to the pill at 12 months - analysed by end of study questionnaire.

Secondary outcome measures

1. Unbroken use of the pill
2. Time to first break in pill use
3. User satisfaction with contraceptive method at over 12 months
4. User satisfaction with bleeding pattern over 12 months
5. Irregular bleeding over 12 months
6. Other side effects
7. Switching to another pill over 12 months
8. Switching to another method of contraception over 12 months

The secondary outcomes will be assessed by women attending their follow up appointments and by their end of study questionnaire at 12 months.

Overall trial start date

01/10/2008

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Females greater than or equal to 18 and less than or equal to 45 years of age
2. Requesting combined oral contraceptive (COC) as future or ongoing contraceptive method and for this to be an appropriate choice
3. Willing to be randomised to one of the two groups
4. Willing to follow protocol for 12 months
5. Able to give written consent
6. Access to the internet, has an email address and mobile phone
7. Willing to complete an online diary regularly, i.e. weekly, for up to 12 months after starting the allocated regimen

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500 - 600

Participant exclusion criteria

Any recognised contraindications to COC (UK Medical Eligibility Criteria [UKMEC] points 3 and 4, 2007).

Recruitment start date

01/10/2008

Recruitment end date

31/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Research Unit
London
W1T 4PL
United Kingdom

Sponsor information

Organisation

Camden Primary Care Trust (UK)

Sponsor details

Research and Development Department
Research Unit
3rd Floor West Wing
St Pancras Hospital
London
NW1 0PE
United Kingdom
+44 (0)20 7530 5375
angela.williams@camdenpct.nhs.uk

Sponsor type

Government

Website

http://www.camdenpct.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0906-11154)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes