New Treatments for Troublesome Bleeding in Implanon Users
Information source: Family Planning Association New South Wales
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Menstrual Problem
Intervention: Marvelon (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Family Planning Association New South Wales Official(s) and/or principal investigator(s):
Edith Weisberg, MB BS MM, Principal Investigator, Affiliation: Family Planning NSW
Ian S FRASER, BSC MD, Principal Investigator, Affiliation: University of Sydney
Overall contact:
Edith Weisberg, MB BS MM FRANZCOG, Phone: +61 2 8752 4342, Email: edithw@fpnsw.org.au
Summary
Most Implanon users experience a reduction in the frequency and volume of menstrual
bleeding, but a substantial minority experience unpredictable and frequent and/or prolonged
episodes of bleeding. This is a double blind, placebo controlled, randomised study with an
additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years,
who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition)
will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to
Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a
daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be
enrolled into the treatment phase provided that they have met one of the World Health
Organization criteria for prolonged or frequent bleeding Following the initial 90 day
record, eligible women will begin designated treatment on day 1 of the next episode of
bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of
that bleeding/spotting episode and will continue through 90 days.
Clinical Details
Official title: Phase 4 Study Comparison of Two Combined Oral Contraceptive Regimens and an Intravaginal Hormonal Ring Against Placebo for Management of Bleeding Problems in Women Using Implanon, the Sub-dermal Contraceptive Implant
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The number of days to stop bleeding after initiation of each treatment group and placebo
Secondary outcome: The mean total number of bleeding and spotting days during the 90 day "treatment" reference period
Detailed description:
This is a double blind, placebo controlled, randomised study with an additional randomised
non-blinded arm. Two hundred women between the ages of 18-45 years, who are Implanon users
with prolonged or frequent breakthrough bleeding (WHO definition) will be recruited and
randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon 7 days or 21
days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily menstrual diary
chart for a minimum of 90 days prior to randomisation, and will be enrolled into the
treatment phase provided that they have met one of the World Health Organization criteria
for prolonged or frequent bleeding (in the 90 day reference period one episode of bleeding
and/or spotting lasting > 10 days, or more than 4 bleeding/spotting episodes). Randomisation
will be performed by computer generation of a random number table in blocks of ten, with
equal numbers in each of the four groups. The medications will be packed in sequentially
numbered and sealed opaque envelopes (independent of the investigators).
Following the initial 90 day record, eligible women will begin designated treatment on day 1
of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern
will begin from day 1 of that bleeding/spotting episode and will continue through 90 days.
Analysis of the pre-treatment menstrual pattern will include the 90 days immediately
preceding the bleeding episode in which treatment starts.
Women will participate in the study for approximately seven months depending on their
bleeding pattern.
Data analysis:
Data will be analysed on an intention to treat basis, entered on SPSS and analysed prior to
breaking the randomisation code. Frequency analyses will be undertaken for demographic data
and means (SD) compared to check effectiveness of the randomisation scheme. Total number of
days of spotting, bleeding, bleeding and spotting and number of episodes during the pre and
post 90 days reference period will be entered.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant
and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual
diary for 6 months
Exclusion Criteria:
Women who have currently or previously had
- Heart attack or stroke
- Blood clot in a vein
- High blood pressure
- Severe liver or kidney disease
- Blood pressure > 135 mm systolic or >85 mm diastolic
- Migraine with aura
- Breast cancer or any genital cancer
- Severe chronic liver or kidney disease
- Women with known sensitivity to ethinyl oestradiol, progestogens
- Women taking phenytoin, carbamazepine or phenobarbitol
- Women who are pregnant
- Women who are lactating
- Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to
follow the study criteria
Locations and Contacts
Edith Weisberg, MB BS MM FRANZCOG, Phone: +61 2 8752 4342, Email: edithw@fpnsw.org.au
Sydney centre for Reproductive Health Research, FPNSW, Sydney, New South Wales 2131, Australia; Not yet recruiting
Edith Weisberg, MB BS MM, Principal Investigator
Additional Information
Related publications: Weisberg E, Hickey M, Palmer D, O'Connor V, Salamonsen LA, Findlay JK, Fraser IS. A randomized controlled trial of treatment options for troublesome uterine bleeding in Implanon users. Hum Reprod. 2009 Aug;24(8):1852-61. Epub 2009 Apr 15.
Starting date: July 2011
Last updated: June 28, 2011
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