Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively 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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/07/2016: No publications found, verifying study status with principal investigator