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van CCT (UK)


Effects of early luteal phase estrogen and progesterone administration on luteolysis in normo-ovulatory women.


- candidate number1803
- NTR NumberNTR516
- ISRCTNIncomplete data for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-nov-2005
- Secondary IDsVPG 03.01 
- Public TitleEffects of early luteal phase estrogen and progesterone administration on luteolysis in normo-ovulatory women.
- Scientific TitleEffects of early luteal phase estrogen and progesterone administration on luteolysis in normo-ovulatory women.
- ACRONYMN/A
- hypothesisThe hypothesis will be tested that early luteal phase administration of high dosages of Estradiol and/or Progesterone in normo-ovulatory volunteers will reduce the luteal phase length.
- Healt Condition(s) or Problem(s) studiedNo condition, healthy person
- Inclusion criteria1. Regular menstrual cycle (25-34 days);
2. normal body weight (BMI 18-28);
3. normal reproductive age (20-37 yrs);
4. normal early follicular phase FSH levels.
- Exclusion criteria1. Known or suspected pregnancy;
2. the use of oral contraceptives (i.e. ProveraŽ, MirenaŽ, Nuva ringŽ ect.) in the last three months;
3. smoking habit;
4. subjects suffering from epilepsy;
5. diabetes mellitus;
6. gastrointestinal, hepatic, renal, and/or pulmonary diseases;
7. abnormal history;
8. use of other investigational drugs within 3 months and/or use of hormonal preparations-other then dose used for COH-within 1 month prior to the start of the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2003
- planned closingdate1-mei-2005
- Target number of participants40
- InterventionsE2 group: 8 Fem 7 patches (Estradiol 0.1 mg/cm2 Merck BV, Amsterdam, the Netherlands) applied on the buttocks on the day of the observed LH surge combined with 4 puffs (600ėg) AerdiolŽ (Estrogen 150 ėg/spray, Servier, Leiden, the Netherlands) every 3 hours on the day of LH. The patches were removed after the blood sampling on day LH+4. P group: Prontogest i.m injections (Progesterone amp, 100 mg/ml, AMSA, Roma, Italia). Started on day LH+4: evening 25 mg; LH+5; morning 100 mg and evening 150 mg; LH+6: morning 300 mg and evening 300 mg.
E+P group: combination of above-mentioned regimens.
Non-treatment group; no medication.
- Primary outcomeDuration of the luteal phase. Every subject will undergo an end of trial visit. In this visit the subjects will hand over a paper on wich she will write down the onset of the menstuation. These data will be put into a excel database.
- Secondary outcomeEndocrine profiles. Blood will be sampled every other day in the luteal phase from the day of the positive LH test until day LH+14.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. dr. J.T. Dissel, van
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.T. Dissel, van
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsEur J Endocrinol. 2006 Aug;155(2):355-63.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-nov-2005 - 9-jul-2008


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