|- candidate number||4124|
|- NTR Number||NTR1460|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-sep-2008|
|- Secondary IDs||PR3082 Protocol nummer van Pantarhei Bioscience|
|- Public Title||Study to investigate the effects of adding an androgen to oral contraception (OC) on mood disturbances experienced during OC use.|
|- Scientific Title||Double-blind, placebo-controlled, randomised N=1 study to determine the effect of concomitant treatment with dehydroepiandrosterone on mood in women who experience mood disturbances during oral contraception-use|
|- Healt Condition(s) or Problem(s) studied||Emotions, Oral contraception (OC)|
|- Inclusion criteria||1. Women using oral contraceptives for at least 3 months prior to screening and aged 20-35 years (inclusive) (for subgroup: Women, aged 20-40 years (inclusive), using a non-hormonal contraceptive method for at least 3 months and willing to use an OC for 6 subsequent cycles).|
2. Report of mood disturbances, and attributing this to OC use as evidenced by in depth interview independently performed by two investigators.
3. Regular menstrual cycles (24-35 days) prior to last start of OC use.
4. Body mass index between (≥) 18 and (≤) 35 kg/m2.
5. Good physical and mental health as judged by the Investigator determined by medical and gynaecological history, physical examination, clinical laboratory and vital signs.
6. Willing to give informed consent in writing.
|- Exclusion criteria||1. Use of non-oral hormonal contraception in the 3 months prior to the screening (for subgroup: Use of oral hormonal contraception in the 3 months prior to the screening).|
2. Intention to become pregnant during the study.
3. Lactation and/or pregnancy in the previous 6 months prior to screening.
4. Any clinically significant abnormality following review of medical and gynaecological history, clinical laboratory (haematology, biochemistry and androgen parameters) and physical examination and vital signs.
5. Contraindications for contraceptive steroids.
6. Use of one or more of the following medications:
- Psychoactive drugs
- Antihypertensive drugs
- Sex steroids other than the current OC
- Use at present or within 30 days before start study medication:
hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin, nelfinavir, ritonavir and St. John’s wort (Hypericum perforatum)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2008|
|- planned closingdate||1-jul-2008|
|- Target number of participants||12|
|- Interventions||All participants will receive two tablets of study medication, which will be ingested daily during the first 21 days of every cycle. These tablets will either contain DHEA or placebo. During the pill-free period (day 22 – 28), there is no intake of study medication. Total treatment duration: 6 cycles of 28 days each with a randomised monthly regimen (3 cycles placebo and 3 cycles DHEA). All participants will continue using their regular OC.
The effect of concomitant DHEA compared to placebo in OC users on mood disturbances will be measured with a daily mood rating. This is a daily rating on a 5-point scale (1 meaning very negative, and 5 meaning very positive) included in the Study Diary.|
|- Primary outcome||Primary objective is to evaluate the effect of DHEA on mood disturbances during OC use
|- Secondary outcome||- To assess general effects on well-being |
- To assess satisfaction and health related quality of life
|- Timepoints||6 cycles of 28 days per subject|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. F.J.M.E. Roumen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F.J.M.E. Roumen|
|- Sponsor/Initiator ||Atrium Medisch Centrum Parkstad|
(Source(s) of Monetary or Material Support)
|- Brief summary||Design: |
A double-blind, placebo-controlled, randomised N=1 study
Main group: Six healthy OC users who complain of mood disturbances during OC use only
Subgroup (optional): Six healthy women who have had complaints of severe mood disturbances during OC use only and are willing to use OC for 6 subsequent cycles (= 28 days per cycle)
All participants will receive two tablets of study medication, which will be ingested daily during the first 21 days of every cycle. These tablets will either contain DHEA or placebo. During the pill-free period (day 22 – 28), there is no intake of study medication.
Total treatment duration:
6 cycles of 28 days each with a randomised monthly regimen (3 cycles placebo and 3 cycles DHEA)
All participants will continue using their regular OC.
To evaluate the effect of DHEA on mood disturbances during OC use
· To assess the general effects on well-being
· To assess satisfaction and health related quality of life
· Daily mood rating (1-5)
· General effect of study medication on subject’s well-being over the past 3 weeks
· Satisfaction and health related quality of life over the past week of OC intake
|- Main changes (audit trail)|
|- RECORD||26-sep-2008 - 4-jun-2011|