A study of two different ways of taking the combined oral contraceptive pill to establish whether the way it is taken affects how many women are still taking the pill after one year.

The Effects of Standard vs. Tailored use of the Combined Oral Contraceptive on Continuation Rates at one year. - Standard vs Tailored pill taking

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005453-36-GB

Enrollment

500

Registered

2008-01-25

Start date

2009-02-19

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A randomised controlled trial 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 one year. MedDRA version: 13.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Microgynon 30 combined oral contraceptive pill (levonrgestrel 150mcg and ethinylestradiol 30mcg) Product Name: Microgynon 30 Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Females 18 to 45 years of age inclusive Requesting COC as future or ongoing method of contraception and for this method to be an apprpriate choice Willing to be randomised to one of the two groups Willing to follow protocol for 12 months Able to provide written consent Access to the internet, has an email address and willing to complete an online diary regularly, i.e. weekly for up to 12 months after starting the allocated regimen Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Currently on medication which may influence the efficacy of COC Any recognised (WHO eligibility criteria 3&4 ) contraindication to COC (UKMEC, 2007) Unable or unwilling to complete online diary for 12 months Unable to provide written consent

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary objectives are to compare, across the two arms of the trial, the proportion of women reporting: 1- adherence 2- user satisfaction with way of taking COC 3- bleeding, both spotting and heavier bleeding 4- other side effects (known or perceived) 5- switching to another way of taing COC 6- switching to another method of contraception 7- pregnancy ;Timepoint(s) of evaluation of this end point: one year;Main Objective: The primary objective of the trial is to compare two alternative ways of taking COC to determine which is associated with better continuation rates. Which of the two regimens is associated with the highest proportion of women continuing to take COC at 12 months.;Primary end point(s): The primary objective of the trial is to coampare two alternative ways of taking COC to determine which is associated with better continuation rates. As measured by the proportion of women continuing to take COC at 12 months.	—

Measure

Time frame

Secondary Objective: The secondary objectives are to compare, across the two arms of the trial, the proportion of women reporting: 1- adherence 2- user satisfaction with way of taking COC 3- bleeding, both spotting and heavier bleeding 4- other side effects (known or perceived) 5- switching to another way of taing COC 6- switching to another method of contraception 7- pregnancy ;Timepoint(s) of evaluation of this end point: one year;Main Objective: The primary objective of the trial is to compare two alternative ways of taking COC to determine which is associated with better continuation rates. Which of the two regimens is associated with the highest proportion of women continuing to take COC at 12 months.;Primary end point(s): The primary objective of the trial is to coampare two alternative ways of taking COC to determine which is associated with better continuation rates. As measured by the proportion of women continuing to take COC at 12 months.

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Countries

United Kingdom

Contacts

Public ContactCo-ordinating Centre

Margaret Pyke Centre

02033175497

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026