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
| ISRCTN | ISRCTN42638345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42638345 |
| Secondary identifying numbers | N0530128908 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 11/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jo Power
Scientific
Scientific
Margaret Pyke Centre
73 Charlotte Street
London
W1T 4PL
United Kingdom
| Phone | +44 (0)20 7 530 3640 |
|---|---|
| jopower1@hotmail.com |
Study information
| Study design | Randomised controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Pelvic pain |
| Intervention | Comparison of two different progesterone only pills, Cerazette and Femulen |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/03/2003 |
| Completion date | 30/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 25 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 30/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Margaret Pyke Centre
London
W1T 4PL
United Kingdom
W1T 4PL
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
North Central London Research Consortium (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/07/2016: No publications found, verifying study status with principal investigator
