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- Klinische proef NCT00796133
A Phase 2, Dose-finding, Cross-over Study to Evaluate the Effect of a NES/E2 Transdermal Gel Delivery on Ovulation Suppression in Normal Ovulating Women
16 april 2015 bijgewerkt door: Population Council
This is a Phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Verwacht)
18
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Santiago, Chili
- Instituto Chileno de Medicina Reproductiva
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Santo Domingo, Dominicaanse Republiek
- Profamilia
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California
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Los Angeles, California, Verenigde Staten, 90033
- Women's and Children's Hospital; LA County/USC Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 40 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Woman is between 18 and 40 years of age
- Has intact uterus and ovaries
- Has regular menstrual cycles of 25-35 days duration
- Able to comply with the protocol, including frequent blood sampling, and lives within the catchment area of the clinic
- Understands the study procedures and agrees to participate in the study by giving written informed consent
- Able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm) with every act of intercourse, or has been sterilized with tubal ligation, or only male partner has been sterilized with vasectomy
- Progesterone >10 nmol/L in at least one sample in the lead-in cycle
Exclusion Criteria:
- All contraindications to OC use including
- Thrombophlebitis or thromboembolic disorders
- Past history of deep vein thrombophlebitis or thromboembolic disorders
- Past or current cerebrovascular or coronary artery disease
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas or carcinomas
- Woman has a history of headaches with focal neurological symptoms
- Known or suspected pregnancy
- Aged >35 and smoker
- BMI >29
- Positive urine pregnancy test at the screening or baseline visit
- Desired pregnancy within the duration of the study
- Known hypersensitivity to progestins
- Known hypersensitivity to estrogen
- Undiagnosed vaginal discharge or vaginal lesions or abnormalities
- In accordance with the Bethesda system of classification Women with a current abnormal Pap smear suggestive of high-grade pre cancerous lesion(s), including HGSIL, are excluded
- Women with LGSIL or ASCUS/high-risk HPV positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity >CIN I is present and/or endocervical curettage is negative
- Women with a biopsy finding of CIN I should have follow up for this finding per standard of care; women are excluded if treatment is indicated In accordance with other Pap class systems
- Women with high grade dysplasia are excluded
- Women with low grade dysplasia or CIN I interpretation on Pap smear may participate based on investigator discretion in accordance with local standard of care
- Breastfeeding
- Cancer (past history of any carcinoma or sarcoma)
- History of a significant psychiatric disorder, including severe depression.
- Chronic or acute liver or renal disease
- Hypertension-- controlled by medication or defined by diastolic BP 85 mm Hg or systolic BP 135mm Hg after 15 minutes rest
- Dermatitis, psoriasis or other severe skin disorder
- Known or suspected alcoholism or drug abuse
- Clinically significant abnormalities of laboratory safety tests
- Chronic disease or history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- Woman is participating or has participated in another clinical study (involving an investigational drug) within one month prior to enrollment.
- Use of injectable contraceptives during the previous 3 months (e.g. cyclofem) or 9 months (e.g. DMPA)
- Use of oral contraceptives within the past 1 month
- Use of concomitant drugs that may interact with the study drugs
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 1
0.5 ml of NES/E2 equaling 0.45 g and contains 1.5 mg NES/0.5 mg E2
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Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles.
The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES.
Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively.
The doses of Estradiol will also be tailored to the 3 formulations.
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Actieve vergelijker: 2
1.0 ml of NES/E2 gel equaling 0.9 g and contains 3.0 mg NES/1.0 mg E2
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Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles.
The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES.
Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively.
The doses of Estradiol will also be tailored to the 3 formulations.
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Actieve vergelijker: 3
1.5 ml of NES/E2 gel equaling 4.5 mg NES/1.5 mg E2
|
Lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles.
The high dose will deliver 4.5mg of NES; the medium dose will deliver 3mg of NES, and a low dose of 1.5mg of NES.
Based on a 10% absorption rate, 450 µg/d, 300 µg/d and 150 µg/d will be absorbed respectively.
The doses of Estradiol will also be tailored to the 3 formulations.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Determine with ultrasound scan (USS) measures and serum progesterone (P) assessment the lowest effective dose of 3 formulations of the NES/E2 gel to ensure ovulation suppression (P<10nmol/L) in 90-95% of the cycles
Tijdsspanne: Subjects will remain in the study for approximately 8 months
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Subjects will remain in the study for approximately 8 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Determine with USS and E2 serum levels the dose that can suppress follicle growth and replace estradiol at the physiological early follicular phase level
Tijdsspanne: Subjects will remain in the study for approximately 8 months
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Subjects will remain in the study for approximately 8 months
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Evaluate the correlation of NES and E2 serum levels with the percentage of ovulation suppression
Tijdsspanne: Subjects will remain in the study for approximately 8 months
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Subjects will remain in the study for approximately 8 months
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Evaluate the safety and tolerability of the formulations
Tijdsspanne: Subjects will remain in the study for approximately 8 months
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Subjects will remain in the study for approximately 8 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2008
Primaire voltooiing (Werkelijk)
1 januari 2014
Studie voltooiing (Werkelijk)
1 januari 2014
Studieregistratiedata
Eerst ingediend
21 november 2008
Eerst ingediend dat voldeed aan de QC-criteria
21 november 2008
Eerst geplaatst (Schatting)
24 november 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
17 april 2015
Laatste update ingediend die voldeed aan QC-criteria
16 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Population Council #427
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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