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
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