Contact information
Type
Scientific
Primary contact
Dr Jo Power
ORCID ID
Contact details
Margaret Pyke Centre
73 Charlotte Street
London
W1T 4PL
United Kingdom
+44 (0)20 7 530 3640
jopower1@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0530128908
Study information
Scientific title
A pilot study to assess the feasibility of a RCT to compare the effectiveness of two different progesterone only pills (POP) on reducing pelvic pain
Acronym
Study hypothesis
This pilot study aims to assess if data collected supports the theoretical superiority of Cerazette over Femulen in reducing cyclical pelvic pain. It also aims to assess the feasibility of conducting a larger trial in the future.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Urological and Genital Diseases: Pelvic pain
Intervention
Comparison of two different progesterone only pills, Cerazette and Femulen
Intervention type
Drug
Phase
Not Applicable
Drug names
Cerazette, Femulen
Primary outcome measure
If Cerazette is effective in reducing the pain associated with ovulation and menstruation, it will provide a valuable alternative choice for women who are unable to chose not to take combined oral contraceptives (COCs).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2003
Overall trial end date
30/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Females over 18 years of age who require a method of contraception
2. Willing to follow protocol
3. Able to give written consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
25
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
30/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Margaret Pyke Centre
London
W1T 4PL
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Central London Research Consortium (UK)
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
Basic results (scientific)
Publication list