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 |
| Protocol serial number | N0530128908 |
| Sponsor | Department of Health |
| Funder | North Central London Research Consortium (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled pilot study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cerazette, Femulen |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Margaret Pyke Centre
London
W1T 4PL
United Kingdom
W1T 4PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/07/2016: No publications found, verifying study status with principal investigator
